Government-Owned Inventions; Availability for Licensing, 4730-4743 [2014-01635]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 79, Number 19 (Wednesday, January 29, 2014)]
[Notices]
[Pages 4730-4743]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to 
receive copies of the patent applications.

Novel Targets To Prevent Borrelia burgdorferi Infection and Lyme 
Disease

    Description of Technology: B. burgdorferi-infected ticks can cause 
Lyme disease in mammalian hosts. This technology relates to the use of 
B. burgdorferi outer surface proteins (BBA64 and BBA66) as Lyme disease 
vaccine candidates. In vivo animal studies demonstrate these outer 
surface proteins inhibit tick-to-host B. burgdorferi transmission. 
Presently, there is no vaccine approved for Lyme disease.
    This technology may also be used for creation of antibodies 
directed against B. burgdorferi. Thus, this innovation may prevent B. 
burgdorferi infection by passive immunity and provide new diagnostic 
tools, which will allow early intervention.
    Potential Commercial Applications:
     B. burgdorferi/Lyme disease vaccine development
     B. burgdorferi diagnostics
     Prevention of B. burgdorferi infection by passive immunity
     Zoonotic/tick-borne disease surveillance
     Public health vaccination programs against Lyme disease
    Competitive Advantages: Currently no approved Lyme disease vaccines
    Development Stage:
     Early-stage
     In vitro data available
     In vivo data available (animal)
    Inventor: Robert D. Gilmore (CDC)
    Publication: Patton TG, et al. Borrelia burgdorferi bba66 gene 
inactivation results in attenuated mouse infection by tick 
transmission. Infect Immun. 2013 Jul;81(7):2488-98. [PMID 23630963]
    Intellectual Property: HHS Reference No. E-573-2013/0--US 
Provisional Application No 61/814,741 filed 22 Apr 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Real-Time RT-PCR Assay for Detection and Quantification of Hepatitis D 
Virus Infection

    Description of Technology: CDC scientists have developed a one-step 
TaqMan quantitative/real-time reverse transcription-polymerase chain 
reaction (qRT-PCR) assay for detecting hepatitis D virus (HDV) RNA. 
Additionally, a quantifiable synthetic RNA control to determine viral 
load has been created.
    HDV is an operatively defective virus that requires hepatitis B 
virus (HBV) surface antigen (HBsAg) for its assembly. Compared to 
individuals infected with HBV alone, individuals infected with both HDV 
and HBV

[[Page 4731]]

viruses present with more severe hepatitis, progress to liver disease 
more quickly, and have a higher mortality rate. Currently, there are no 
regulated tests available for detection and quantification of HDV RNA. 
This assay directly addresses this unmet need and has been validated 
with clinical samples of HDV genotypes 1 and 3. It has the potential to 
detect all eight HDV genotypes.
    Potential Commercial Applications:
     Development of a commercial nucleic acid assay for 
diagnosis of current hepatitis D virus (HDV) infection
     Public health and vaccination programs
     Testing of individuals infected with hepatitis B and/or 
liver disease
    Competitive Advantages:
     Rapid, accurate, inexpensive and stable
     Unique RNA transcript for this assay can be successfully 
used as a quantitative standard
     Current anti-HDV antibody assay identifies individuals 
exposed to HDV, but cannot identify current infection
     Easily adapted for inclusion in a hepatitis testing kit, 
especially when paired with a hepatitis B diagnostic
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Maja Kodani, Tonya Mixson-Hayden, Saleem Kamili (all of 
CDC)
    Publication: Kodani M, et al. One-step real-time PCR assay for 
detection and quantitation of hepatitis D virus RNA. J Virol Methods. 
2013 Nov;193(2):531-5. [PMID 23896020]
    Intellectual Property: HHS Reference No. E-510-2013/0--US 
Provisional Application No. 61/792,293 filed 15 Mar 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Reduced Virulence Crimean-Congo Hemorrhagic Fever Virus for Vaccine 
Development

    Description of Technology: This invention relates to a genetically 
modified hemorrhagic fever virus that can be used as an effective live 
vaccine agent. Hemorrhagic fever evades the human immune response using 
the viral ovarian tumor domain (vOTU) protease, which inhibits critical 
host-immunity functions. The present genetically modified virus has a 
vOTU protease with decreased ability to remove ubiquitin (Ub) and ISG15 
tags from proteins in cells it infects. Thus, the virulence is reduced, 
creating an immunogenic and non-pathogenic virus for use as a live 
vaccine against Crimean-Congo hemorrhagic fever (CCHF) virus. Unlike 
strains with complete ablation of the vOTU protease, the present 
modified virus retains enough activity for replication in a human cell 
line, making vaccine production possible. This technology may be used 
to create vaccines or therapeutics for other nairoviruses, including 
the Dugbe, Hazara, and Nairobi sheep disease viruses.
    Potential Commercial Applications: Development of vaccines or 
therapeutics for CCHF virus and other nairoviruses, including Dugbe, 
Hazara and Nairobi sheep disease viruses
    Competitive Advantages:
     Increased safety for CCHF laboratory research (Biosafety 
Level 2)
     Use of human cell lines allows large-scale manufacturing 
of vaccines
     vOTU domain-disruption may be used to develop vaccines for 
all nairovirus viruses affecting humans and/or livestock
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Eric Bergeron (CDC), Stuart T. Nichol (CDC), et al.
    Publications:
    1. Bergeron E, et al. Crimean-Congo hemorrhagic fever virus-encoded 
ovarian tumor protease activity is dispensable for virus RNA polymerase 
function. J Virol. 2010 Jan;84(1):216-26. [PMID 19864393]
    2. Capodagli GC, et al. Structural analysis of a viral ovarian 
tumor domain protease from the Crimean-Congo hemorrhagic fever virus in 
complex with covalently bonded ubiquitin. J Virol. 2011 Apr;85(7):3621-
30. [PMID 21228232]
    Intellectual Property: HHS Reference No. E-486-2013/0--
     US Provisional Application No. 61/683,132 filed 14 Aug 
2012
     US Patent Application No. 13/829,105 filed 14 Mar 2013
     PCT Application No. PCT/US13/54760 filed 13 Aug 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Human Influenza Virus Real-Time RT-PCR Detection and Characterization 
Panel

    Description of Technology: This invention relates to methods of 
rapidly detecting influenza, including differentiating between type and 
subtype. Unlike culture and serological tests requiring 5 to 14 days 
for completion, CDC researchers developed a rapid, accurate assay, 
which is easily adapted to kit form. This assay also requires less 
labor input than immunoassays. These methods can be used to quickly 
identify a broad variety of influenza types and subtypes, including 
viruses that may be involved in pandemics (such as H5N1, for example).
    Potential Commercial Applications:
     Influenza diagnostic using clinical specimens
     High-throughput screenings
     Influenza surveillance programs
    Competitive Advantages:
     Already FDA approved
     Especially useful for H5N1 screening
     Sensitive detection
     Specific discrimination of influenza subtypes
     Easily formatted as kit or array
     Faster than culturing and serological identification 
methods
     Less laborious and more objective than immunoassays
    Development Stage: In vitro data available
    Inventors: Stephen Lindstrom, Alexander I. Klimov, Nancy J. Cox, 
Lamorris Loftin (all of CDC)
    Publication: Jernigan DB, et al. Detecting 2009 pandemic influenza 
A (H1N1) virus infection: availability of diagnostic testing led to 
rapid pandemic response. Clin Infect Dis. 2011 Jan 1;52 Suppl 1:S36-43. 
[PMID 21342897]
    Intellectual Property: HHS Reference No. E-331-2013/0--
     PCT Application No. PCT/US2007/003646 filed 12 Feb 2007, 
which published as WO 2007/095155 on 23 Aug 2007
     US Patent No. 8,241,853 issued 14 Aug 2012
     US Patent No. 8,568,981 issued 29 Oct 2013
     US Patent Application No. 14/056,810 filed 17 Oct 2013
     Various international patent applications pending or 
issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Peptide Vaccines Against Group A Streptococci

    Description of Technology: This invention relates to synthetic 
immunoreactive peptides, which are portions of the M proteins of the 
most prevalent Group A Streptococcus (GAS) serotypes in the United 
States. These peptides may be useful in development of a flexible, 
multivalent GAS vaccine. They can be recognized by M type-specific 
antibodies and are capable of eliciting functional opsonic antibodies. 
Additionally, the peptides or isolated antibodies raised in response to 
the peptides may be useful for GAS diagnostics.

[[Page 4732]]

    Potential Commercial Applications:
     Group A streptococci (GAS) vaccine
     GAS therapeutics and diagnostics
     Lab tools for exploring GAS
    Competitive Advantages:
     Easily adaptable to kit form
     Multivalent vaccine that can be tailored for protection 
against specific GAS serotypes affecting a particular population
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Bernard W. Beall, George M. Carlone, Jacquelyn S. 
Sampson, Edwin W. Ades (all of CDC)
    Publication: Bruner M, et al. Evaluation of synthetic, M type-
specific peptides as antigens in a multivalent group A streptococcal 
vaccine. Vaccine. 2003 Jun 20;21(21-22):2698-703. [PMID 12798606]
    Intellectual Property: HHS Reference No. E-330-2013/0--
     US Patent No. 7,407,664 issued 05 Aug 2008
     US Patent No. 7,883,710 issued 08 Feb 2011
     US Patent No. 8,420,107 issued 16 Apr 2013
     US Patent Application No. 13/846,166 filed 18 Mar 2013
     Various international patent applications pending or 
issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Method of Enhancing Opsonophagocytosis

    Description of Technology: This invention aims to bolster the human 
body's own mechanisms to fight infection by enhancing an innate immune 
response, opsonophagocytosis. The specific 24 amino acid sequence (P4) 
acts as a polymorphonuclear cell activator. P4 can be administered in 
vivo along with a disease's specific antibody to enhance systemic 
bacterial clearance, thus leading to prolonged survival. This 
technology enhances the body's response to infections such as S. 
pneumoniae and S. aureus.
    Potential Commercial Applications:
     Opsonic therapy
     Passive immunization
     Enhancement of pathogen clearing
     Synergistic use with other therapies
    Competitive Advantages:
     Multiple in vivo studies indicate significant improvements 
in recipient outcomes
     Highly adaptable and can be combined with a number of 
alternate therapies
     Enhances opsonophagocytosis to achieve therapeutically 
effective results
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Edwin W. Ades, et al. (CDC)
    Publications:
    1. Melnick N, et al. Evaluation of a novel therapeutic approach to 
treating severe pneumococcal infection using a mouse model. Clin 
Vaccine Immunol. 2009 Jun;16(6):806-10. [PMID 19386795]
    2. Weeks JN, et al. Immunotherapy with a combination of intravenous 
immune globulin and p4 peptide rescues mice from postinfluenza 
pneumococcal pneumonia. Antimicrob Agents Chemother. 2011 
May;55(5):2276-81. [PMID 21383090]
    3. Bangert M, et al. P4-mediated antibody therapy in an acute model 
of invasive pneumococcal disease. J Infect Dis. 2012 May 1;205(9):1399-
407. [PMID 22457294]
    Intellectual Property: HHS Reference No. E-329-2013/0--
     PCT Application No. PCT/US2009/052384 filed 31 Jul 2009, 
which published as WO 2010/14888 on 04 Feb 2010
     US Patent No. 8,431,134 issued 30 Apr 2013
     US Patent Application No. 13/851,508 filed 27 Mar 2013
     Various international applications pending or issued
    Related Technologies: HHS Reference No. E-338-2013/0--
     PCT Application No. PCT/US2005/027290 filed 29 Jul 2005, 
which published as WO 2006/127020 on 30 Nov 2006
     US Patent No. 7,919,104 issued 05 Apr 2011
     Australia Patent No. 2005332058 issued 15 Mar 2012
     Various international patent applications pending or 
issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.
    Collaborative Research Opportunity: The Centers for Disease Control 
and Prevention (CDC) is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize Methods and Tools for Enhancing 
Opsonophagocytosis in Response to a Pathogen. For collaboration 
opportunities, please contact Suzanne Shope at sshope@cdc.gov or 770-
488-8613.

Novel Live-Attenuated Rabies Vaccine

    Description of Technology: The critical feature of this technology 
is the Evelyn-Rokitnicki-Abelseth (ERA) rabies whole genome DNA 
sequence. With the availability of the entire rabies genome, a 
recombinant vaccine can be developed using reverse genetics. Using this 
technology, CDC researchers have developed a recombinant, live-
attenuated vaccine shown to confer protection against lethal doses of 
live, street-rabies virus in multiple survival studies. This vaccine 
offers better protection than traditional inactivated vaccinations, as 
demonstrated in co-infection studies. Further, a single intramuscular 
vaccination with the CDC's attenuated-virus was sufficient for survival 
of 100% of hamsters and mice following lethal challenge.
    Potential Commercial Applications:
     Rabies vaccine design and development
     Immunogenic compositions for both prevention and treatment 
of rabies virus
     Rabies virus research
    Competitive Advantages:
     Live attenuated vaccine shows greater efficacy than older 
inactivated vaccine
     100% animal survival conferred by a single inoculation 
before lethal challenge
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Charles E. Rupprecht and Xianfu Wu (CDC)
    Publications:
    1. Wu X, et al. Are all lyssavirus genes equal for phylogenetic 
analyses? Virus Res. 2007 Nov;129(2):91-103. [PMID 17681631]
    2. Bankovskiy D, et al. Immunogenicity of the ERA G 333 rabies 
virus strain in foxes and raccoon dogs. Dev Biol (Basel). 2008;131:461-
6. [PMID 18634508]
    3. Wu X, Rupprecht CE. Glycoprotein gene relocation in rabies 
virus. Virus Res. 2008 Jan;131(1):95-9. [PMID 17850911]
    4. Franka R, et al. Rabies virus pathogenesis in relationship to 
intervention with inactivated and attenuated rabies vaccines. Vaccine. 
2009 Nov 27;27(51):7149-55. [PMID 19925945]
    5. Wu X, et al. Live attenuated rabies virus co-infected with 
street rabies virus protects animals against rabies. Vaccine. 2011 Jun 
6;29(25):4195-201. [PMID 21514343]
    Intellectual Property: HHS Reference No. E-326-2013/0--
     PCT Application No. PCT/US2006/040134 filed 13 Oct 2006, 
which published as WO 2007/047459 on 26 Apr 2007
     US Patent No. 7,863,041 issued 04 Jan 2011

[[Page 4733]]

     US Patent Application No. 12/956,949 filed 30 Nov 2010
     Various international patent applications pending or 
issued
    Related Technologies: HHS Reference No. E-256-2013/0--
     PCT Application No. PCT/US2011/041579 filed 23 June 2011, 
which published as WO 2011/163446 on 29 Dec 2011
     US Patent Application No. 13/806,622 filed 21 Dec 2012
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Intranasal Nebulizer With Disposable Drug Cartridge for Improved 
Delivery of Vaccines and Therapeutics

    Description of Technology: Intranasal delivery is a simple, 
inexpensive and needle-free route for administration of vaccines and 
therapeutics. This intranasal delivery technology, developed with 
Creare, Inc., includes low-cost, disposable drug cartridges (DDCs) that 
mate with a durable hand-held device. The rechargeable-battery-powered 
device transmits ultrasonic energy to the DDC to aerosolize the drug 
and is capable of performing for eight hours at 120 vaccinations per 
hour. Potential applications for this platform technology include 
intranasal vaccination (e.g. seasonal or pandemic influenza vaccines) 
and intranasal delivery of locally active (e.g. antihistamines, 
steroids) or systemically active (e.g. pain medications, sedatives) 
pharmaceuticals.
    The DDCs themselves offer two unique benefits. First, all 
components that contact the active agent or the patient may be easily 
disposed of, which reduces the risk of patient cross-contamination and 
minimizes cleaning and maintenance requirements of the hand-held 
device. Second, DDCs provide a low-cost and simple method to package 
and distribute individual doses.
    This technology also allows for significant dose-sparing. 
Preliminary studies have shown robust immune responses when this 
technology is used to delivery significantly reduced doses of Live 
Attenuated Influenza Vaccine in animal models. The intranasal nebulizer 
produces droplets sized for optimum depositioning in the nasal airway. 
The small nebulizer droplets essentially ``spray paint'' the internal 
nasal airway, resulting in an increased tissue surface coverage that 
may enable a significant dose reduction. In contrast, currently 
available nasal delivery devices, such as nasal sprays and droppers, do 
not provide efficient intranasal delivery in humans because the large 
droplets they generate fail to coat a significant portion of the nasal 
airway. Large droplets also tend to drip out of the nose or down the 
throat, which can be unpleasant for the patient in addition to wasting 
a sizable portion of the active agent.
    Potential Commercial Applications:
     Intranasal delivery of vaccines and therapeutics
     Childhood vaccination programs, mass immunization 
campaigns, or response to epidemics
    Competitive Advantages:
     Safe, needle-less delivery
     No patient-to-patient contamination
     Long-life, rechargeable battery
     Consistent delivery and dose-sparing
     Nasal delivery of live-attenuated vaccines may be more 
effective than traditional injected vaccines
     Cost-effective
     Reduces biohazard waste
     May be administered by personnel with minimal medical 
training
     Easy means of delivery to children with fear of needles
    Development Stage:
     Prototype
     In vitro data available
     In vivo data available (animal)
    Inventors: Mark J. Papania (CDC), et al.
    Publication: Smith JH, et al. Nebulized live-attenuated influenza 
vaccine provides protection in ferrets at a reduced dose. Vaccine. 2012 
Apr 19;30(19):3026-33. [PMID 22075083]
    Intellectual Property:
     HHS Reference No. E-323-2013/0--
--PCT Application No. PCT/US2002/007973 filed 13 Mar 2002, which 
published as WO 2002/074372 on 26 Sep 2002
--US Patent No. 7,225,807 issued 05 Jun 2007
--US Patent No. 8,544,462 issued 01 Oct 2013
--Various international issued patents
     HHS Reference No. E-324-2013/0--
--PCT Application No. PCT/US2005/011086 filed 01 Apr 2005, which 
published as WO 2006/006963 on 19 Jan 2006
--US Patent No. 7,954,486 issued 07 Jun 2011
--US Patent Application No. 13/099,261 filed 02 May 2011
--Various international issued patents
     HHS Reference No. E-308-2013/0--
--PCT Application No. PCT/US2011/039020 filed on 03 Jun 2011, which 
published as WO 2011/153406 on 08 Dec 2011
--US Patent Application No. 13/701,992 filed 04 Dec 2012
--Various international pending patents
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Multiplexed Immunoassay for Rapid Serological Diagnosis of a Specific 
Viral Infection in Clinical Samples

    Description of Technology: CDC researchers have developed a 
multiplexed diagnostic assay for sensitive detection and distinction 
between viral group members based on the presence/absence of infection-
generated antibodies within a clinical serum sample. For example, this 
assay can be used for rapid discrimination of a clinical unknown as 
specifically a West Nile or St. Louis encephalitis viral infection. 
This is particularly beneficial as these two viruses are typically 
difficult to distinguish by standard serological assays.
    This new technique uses microsphere/microbead-based flow-analysis 
as a platform. Because of a basis in a pre-existing technology, the 
technique can be easily incorporated into current state and health 
department diagnostic testing protocols. The method is particularly 
unique because the assay-generated data can be standardized and then 
classified via discriminant analysis to determine the presence or 
absence of antibodies of interest within the clinical sample tested.
    Furthermore, along with allowances for single-result generation, 
data manipulation and classification algorithms allow for assay output 
comparisons to the original large data set references used in 
development. In this way, results from different laboratories can now 
be directly compared to one another, provided that the same controls 
are used.
    Potential Commercial Applications:
     Clinical diagnostics for specific identification and 
discrimination of viral infections
     Research tool for evaluation of vaccine candidates
     Assay standardization and quality control
     Public health and viral outbreak surveillance programs
    Competitive Advantages:
     Increased efficiency compared to single-antibody 
diagnostic approaches
     Easily implemented and integrated into present protocols 
and techniques, as this technology is based on current, widely used 
flow-analysis platforms
     Can be formatted as customizable kits for detection of 
viral group antibodies
     Rapid and precise
     Ideal for high-throughput analyses

[[Page 4734]]

    Development Stage: In vitro data available
    Inventors: Alison J. Basile and Bradley J. Biggerstaff (CDC)
    Publications:
    1. Basile AJ, et al. Removal of species constraints in antibody 
detection. Clin Vaccine Immunol. 2010 Jan;17(1):56-61. [PMID 19923570]
    2. Basile AJ, et al. Multiplex microsphere immunoassays for the 
detection of IgM and IgG to arboviral diseases. PLoS One. 2013 Sep 
25;8(9):e75670. [PMID 24086608]
    Intellectual Property: HHS Reference No. E-302-2013/0--
     US Patent No. 7,933,721 issued 26 Apr 2011
     US Patent No. 8,433,523 issued 30 Apr 2013
     Various international patent applications pending or 
issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Real-Time PCR Multiplex Assay for Detection of Bacterial Respiratory 
Pathogens in Clinical Specimens

    Description of Technology: CDC researchers have developed a single-
tube, real-time PCR assay for the simultaneous detection of three 
bacterial respiratory pathogens (Mycoplasma pneumoniae, Chlamydiophila 
pneumoniae and Legionella spp.). The assay has an internal control 
testing for presence of human DNA. This four-plex real-time PCR assay 
could potentially become a routine screening test for patients with 
respiratory illness. Ninety four clinical specimens (in a 96-well 
format) can be tested at once. This assay is non-invasive, rapid and 
cost-effective. It has the potential for point-of-care applications in 
population-based pneumonia surveillance.
    Potential Commercial Applications:
     Population-based pneumonia surveillance
     Development of broadly-capable respiratory clinical 
diagnostics
    Competitive Advantages:
     Sensitive and specific
     High-throughput friendly
     Rapid and cost-effective compared to screening for 
individual respiratory pathogens
     Easily developed for use in diagnostic kits
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Jonas Winchell, Agnes Warner, Kathleen Thurman (all of 
CDC)
    Publication: Thurman KA, et al. Detection of Mycoplasma pneumoniae, 
Chlamydia pneumoniae, and Legionella spp. in clinical specimens using a 
single-tube multiplex real-time PCR assay. Diagn Microbiol Infect Dis. 
2011 May;70(1):1-9. [PMID 21397428]
    Intellectual Property: HHS Reference No. E-300-2013/0--
     PCT Application No. PCT/US2011/032749 filed 15 Apr 2011, 
which published as WO 2011/133433 on 27 Oct 2011
     US Patent Application No. 13/641,444 filed 28 Nov 2012
     Various international patent applications pending or 
deferred
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Novel Recombinant Rabies Vaccine Also Capable of Immunocontraception

    Description of Technology: This invention relates to a recombinant, 
attenuated rabies vaccine that is also capable of inhibiting 
reproductive fertility. An Evelyn-Rokitnicki-Abelseth (ERA) rabies 
vaccine backbone, combined with a reproductive-specific protein, such 
as gonadotropin-releasing hormone (GnRH) or the sperm-binding zona-
pellucida-glycoprotein-3 (ZP3) receptor, allows reduction in both 
rabies transmission and uncontrolled reproduction in stray animals. The 
ERA rabies vaccine backbone has previously shown strong efficacy in 
animal studies. This vaccine may be delivered via injection or orally, 
including in an animal's food.
    Potential Commercial Applications:
     Development of rabies and immunocontraceptive vaccines
     Immunogenic compositions for both prevention and treatment 
of rabies virus
     Animal welfare initiatives and rabies vaccination programs
    Competitive Advantages:
     Live, attenuated rabies vaccines show greater efficacy 
than older, inactivated rabies vaccine in prior animal studies
     Potential for oral delivery, enabling vaccination of feral 
and difficult-to-reach animal populations
     Novel approach to simultaneously addressing rabies 
transmission and uncontrolled wild animal reproduction
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Xianfu Wu and Charles E. Rupprecht (CDC)
    Publication: Wu X, et al. Development of combined vaccines for 
rabies and immunocontraception. Vaccine. 2009 Nov 27;27(51):7202-9. 
[PMID 19925954]
    Intellectual Property: HHS Reference No. E-298-2013/0--
     PCT Application No. PCT/US2009/054502 filed 20 Aug 2009, 
which published as WO 2010/033337 on 25 Mar 2010
     US Patent Application No. 13/062,680 filed 07 Mar 2011
     Various international patent applications pending or 
deferred
    Related Technologies:
     HHS Reference No. E-256-2013/0--
--PCT Application No. PCT/US2011/041579 filed 23 June 2011, which 
published as WO 2011/163446 on 20 Dec 2011
--US Patent Application No. 13/806,622 filed 21 Dec 2012
     HHS Reference No. E-326-2013/0--
--PCT Application No. PCT/US2006/040134 filed 13 Oct 2006, which 
published as WO 2007/047459 on 26 Apr 2007
--US Patent No. 7,863,041 issued 04 Jan 2011
--Various international patent applications pending or issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Diagnostic Assays Utilizing Real-Time Taqman or Seminested RT-PCR for 
Parechovirus Detection and Discrimination

    Description of Technology: The CDC developed a real-time reverse 
transcription polymerase chain reaction (RT-PCR) Taqman assay and an 
RT-semi nested PCR (RT-snPCR) assay for the detection of 
parechoviruses. Similar to enteroviruses, parechoviruses are 
responsible for gastrointestinal, respiratory and central nervous 
system infections. All tests target conserved regions in the 
5'nontranslated region (5'NTR) of the parechovirus genome and share 
forward and reverse primers. The Taqman probe and RTsnPCR nested primer 
target the same conserved site but vary in length. Both assays detect 
all known human parechoviruses (PPeV) and Ljungan viruses (LV), unlike 
other published parechovirus 5'NTR assays, which only detect a limited 
number of PPeV types. Both assays are more sensitive than current 
methods (culture and multiple, single-serotype nucleic acid 
amplification assays) and may be used to test isolates or original 
clinical specimens.
    Potential Commercial Applications:
     Diagnostic detection of all known species of Parechovirus 
from clinical samples, including Human parechovirus and Ljungan virus
     Discrimination of specific species and serotypes
     Public health surveillance programs
     Research tool for all lab strains and clinical isolates of 
parechovirus

[[Page 4735]]

    Competitive Advantages:
     Detects all Parechovirus genus members with a single assay
     Rapid, accurate, sensitive and specific
     Cost-effective in terms or resource-input, labor and 
turnaround time
     Does not require culturing
     Easily adaptable to kit form
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: William A. Nix and M. Steven Oberste (CDC)
    Intellectual Property: HHS Reference No. E-295-2013/0--
     PCT Application No. PCT/US2006/016624 filed 01 May 2006, 
which published as WO 2007/133189 on 22 Nov 2007
     US Patent No. 8,048,630 issued 01 Nov 2011
     Australian Patent No. 2006343645 issued 05 Apr 2012
     Various international filings pending or issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov
    Collaborative Research Opportunity: The Centers for Disease Control 
and Prevention (CDC) is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize Diagnostic Assays Utilizing Real-Time Taqman 
or Seminested RT-PCR for Parechovirus Detection and Discrimination. For 
collaboration opportunities, please contact Suzanne Shope at 
sshope@cdc.gov or 770-488-8613.

Simultaneous Detection of Non-Pneumophila Legionella Strains Using 
Real-Time PCR

    Description of Technology: Legionnaires' disease is caused by a 
type of bacteria called Legionella. CDC scientists have developed a 
real-time multiplex PCR assay for diagnosis and identification of 
Legionella strains. The assay consists of five sets of primers 
(targeting L. bozemanii, L. dumoffii, L. feeleii, L. longbeachae, or L. 
micdadei) and corresponding probes. Each probe is labeled with a 
different fluorophore which allows the detection of a particular strain 
in a single tube reaction. Using this assay format, the presence of any 
one of the five pathogenic non-pneumophila strains of Legionella can be 
detected rapidly from clinical or environmental samples. Rapid and 
sensitive identification enables initiation of appropriate antibiotic 
therapy and identification of the source of bacteria so that proper 
public health responses may occur.
    Potential Commercial Applications: Rapid and real-time assay to 
detect the presence of clinically relevant non-pneumophila Legionella 
strains.
    Competitive Advantages:
     Currently available tests are time consuming and labor 
intensive.
     This assay enables rapid identification and 
differentiation on clinically relevant non-pneumophila Legionella 
strains.
     This assay can be used as a standalone confirmatory assay 
for the detection of common non-pneumophila Legionella species or as 
one of the valuable assays in conjunction with other standard assays.
    Inventors: Jonas M. Winchell and Alvaro J. Benitez (CDC)
    Publication: Benitez AJ, Winchell JM. Clinical application of a 
multiplex real-time PCR assay for simultaneous detection of Legionella 
species, Legionella pneumophila, and Legionella pneumophila serogroup 
1. J Clin Microbiol. 2013 Jan;51(1):348-51. [PMID 23135949]
    Intellectual Property:
     HHS Reference No. E-277-2013/0--PCT Application No. PCT/
US2013/030217 filed 11 March 2013, which published as WO 2013/187958 on 
19 Dec 2013
     HHS Reference No. E-277-2013/1--US Patent Application No. 
13/895,898 filed 16 May 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Multiplex Real-Time PCR Assay for Detection of Numerous Bacterial 
Pathogens

    Description of Technology: In order to address a global need for 
rapid, cost-effective, sensitive, and specific assays for many 
pathogens, CDC scientists have developed a broad-use, multiplexed RT-
PCR assay. This comprehensive assay covers numerous pathogens that are 
common causes of infection in neonates and also important to food-
safety. Specifically, this assay (and respective probes, primers, and 
kits) is capable of detecting one or more of Acinetobacter baumannii, 
Pseudomonas aeruginosa, Klebsiella pneumoniae, Toxoplasma gondii, 
Moraxella catarrhalis, Escherichia coli, Shigella, Staphylococcus 
aureus, Pneumocystis jirovecii, Chlamydia trachomatis, Ureaplasma 
urealyticum, Ureaplasma parvum, Ureaplasma spp., Bartonella spp., 
Streptococcus agalactiae, and Neisseria meningitidis in a biological 
sample.
    Potential Commercial Applications:
     Clinical diagnostic for several pathogens
     Drug-resistance surveillance
     Public health monitoring
     En masse food-safety screening
    Competitive Advantages:
     Cost-effective
     Simple to implement
     Rapid, accurate and objectively conclusive
     Easily implemented into kit format
     Ideal for high-throughput scenarios
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Jonas Winchell, Bernard Wolff, Maureen Diaz (all of CDC)
    Publication: Diaz MH, et al. Optimization of Multiple Pathogen 
Detection Using the TaqMan Array Card: Application for a Population-
Based Study of Neonatal Infection. PLoS One. 2013 Jun 21;8(6):e66183. 
[PMID 23805203]
    Intellectual Property: HHS Reference No. E-276-2013/0--
     US Provisional Patent Application No. 61/642,091 filed 03 
May 2012
     PCT Application No. PCT/US13/28034 filed 27 Feb 2013, 
which published as WO 2013/165537 on 07 Nov 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Methods of Detecting and Identifying Both Known and Novel Influenza 
Viruses

    Description of Technology: This invention describes materials and 
methods of detecting novel influenza virus in a sample. As highlighted 
by the recent H1N1 pandemic strain, influenza viruses are constantly 
evolving and novel reassortments can quickly spread around the world.
    The reagents and methods of this particular technology are capable 
of detecting any type of influenza virus (such as influenza A virus, 
influenza B virus, and influenza C virus) in a sample, including novel 
or previously unknown influenza viruses. Such methods and compositions 
are useful for diagnosing influenza virus infection in humans and 
animals.
    Potential Commercial Applications:
     Method of rapid, accurate subtype-screening of influenza 
viruses using ``pan-influenza'' RT-PCR
     Diagnostic tool for clinicians, veterinarians, public 
health programs, food-safety officials, researchers and forensic 
scientists
    Competitive Advantages:
     A full-spectrum, sensitive and specific assay for 
identification of influenza viruses, known and novel
     Easily adaptable for commercial production

[[Page 4736]]

    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Suxiang Tong and Shannon Rogers (CDC)
    Publications:
    1. Fouchier RA, et al. Characterization of a novel influenza A 
virus hemagglutinin subtype (H16) obtained from black-headed gulls. J 
Virol. 2005 Mar;79(5):2814-22. [PMID 15709000]
    2. Fouchier RA, et al. Detection of influenza A viruses from 
different species by PCR amplification of conserved sequences in the 
matrix gene. J Clin Microbiol. 2000 Nov;38(11):4096-101. [PMID 
11060074]
    3. Tong S, et al. Sensitive and broadly reactive reverse 
transcription-PCR assays to detect novel paramyxoviruses. J Clin 
Microbiol. 2008 Aug;46(8):2652-8. [PMID 18579717]
    Intellectual Property: HHS Reference No. E-274-2013/0--
     US Provisional Application No. 61/642,098 filed 03 May 
2012
     PCT Application No. PCT/US2013/029600 filed 07 Mar 2013, 
which published as WO 2013/165551 on 07 Nov 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov
    Collaborative Research Opportunity: The Centers for Disease Control 
and Prevention (CDC) is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize Methods of Detecting and Identifying Both 
Known and Novel Influenza Viruses. For collaboration opportunities, 
please contact Suzanne Shope at sshope@cdc.gov or 770-488-8613.

Nucleic Acid Amplification Technique for Rapid Diagnostic Analysis

    Description of Technology: CDC researchers developed a simple 
target-specific isothermal nucleic acid amplification technique, termed 
Genome Exponential Amplification Reaction (GEAR). The method employs a 
set of four primers (two inner and two outer). The outer primer pair 
targets three specific nucleic acid sequences at a constant 60 [deg]C, 
while the inner pair of primers accelerates and improves the 
sensitivity of the assay.
    The GEAR technique is an improvement over loop-mediated isothermal 
amplification (LAMP) in three ways. First, the GEAR method uses two Tab 
primers which target three genomic regions (corresponding LAMP primers 
target four regions). Second, the GEAR method features complementary 5' 
ends between the forward and reverse primers. Third, the GEAR method 
does not require a second set of outer primers (LAMP requires two 
outermost primers). Additionally, the GEAR isothermal method can be 
performed in a relatively inexpensive water bath or heating block, with 
detection of amplification products by fluorescence, thus making it 
suitable for low resource settings.
    Potential Commercial Applications:
     Rapid diagnostic analysis of biological samples
     Qualitative and quantitative analysis of nucleic acids
     Low-cost diagnostics for malaria, tuberculosis, and other 
infectious diseases
    Competitive Advantages:
     Rapid, portable, cost-effective
     Useful in low resource settings
     A ``single-tube'' assay that eliminates need for thermal 
cyclers or gel electrophoresis
     Unlike many other isothermal amplification approaches, 
GEAR can be efficiently performed at temperatures exceeding 60 [deg]C, 
increasing specificity and accuracy
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Jothikumar Narayanan, Prithiviraj Jothikumar, Vincent R. 
Hill (all of CDC)
    Publication: Prithiviraj J, et al. Rapid detection of microbial DNA 
by a novel isothermal genome exponential amplification reaction (GEAR) 
assay. Biochem Biophys Res Commun. 2012 Apr 20;420(4):738-42. [PMID 
22450319]
    Intellectual Property: HHS Reference No. E-273-2013/0--PCT 
Application No. PCT/US2012/049784 filed 06 Aug 2012
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Diagnostics, Vaccines, and Delivery-Vehicles Related to Novel 
Phlebovirus

    Description of Technology: This CDC invention relates to primers 
and probes that specifically hybridize with Heartland virus (HRTLDV), a 
unique member of the genus Phlebovirus. It further relates to 
polyclonal antibodies specific for HRTLDV proteins. Serological 
detection assays using HRTLDV nucleic acid molecules, proteins, probes, 
primers, and antibodies are provided. Importantly, the HRTLDV genome 
can be engineered using reverse genetics to be attenuated, allowing 
development of a vaccine for other viruses within the Phlebovirus genus 
or Bunyaviridae family. Individual proteins or peptides of the HRTLDV 
can also be used in other FDA-approved virus backbones to act as 
vaccines. Further, since HRTLDV targets the bone marrow, disclosed 
HRTLDV delivery vehicles may be used to deliver therapeutic agents to 
the bone marrow.
    Potential Commercial Applications:
     Development of nucleic acid (RT-PCR) and serologic 
diagnostic assays for phleboviruses
     Phlebovirus vaccines
     Novel delivery vehicles for bone marrow-originating 
diseases
     Research tool for phlebovirus virulence mechanisms
     Vector or tick-borne illness monitoring programs for both 
humans and wildlife
    Competitive Advantages:
     Antigens and antibodies for diagnostic use have been 
developed
     RT-PCR allows rapid, quantitative diagnosis
     Potential use as bone marrow therapeutic delivery tools
     Recombinant, pseudo-phlebovirus reporter systems have 
potential for a wide range of high-throughput drug-screening and 
research applications
    Development Stage:
     Early stage
     In vitro data available
    Inventors: Laura K. McMullan, Cynthia S. Goldsmith, Aubree J. 
Kelly, William L. Nicholson, Stuart T. Nichol (all of CDC)
    Publications:
    1. McMullan LK, et al. A new phlebovirus associated with severe 
febrile illness in Missouri. N Engl J Med. 2012 Aug 30;367(9):834-41. 
[PMID 22931317]
    2. CDC FAQs: Novel phlebovirus (Heartland virus) [https://www.cdc.gov/ncezid/dvbd/heartland/ ]
    Intellectual Property: HHS Reference No. E-269-2013/0--
     US Provisional Patent Application No. 61/614,926 filed 23 
Mar 2012
     PCT Application No. PCT/US2013/033541 filed 22 Mar 2013, 
which published as WO 2013/142808 on 26 Sep 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

HIV-1 Genotyping Assay for Subtype Diagnosis and Global Surveillance of 
Drug Resistance

    Description of Technology: CDC researchers have developed a set of 
RT-PCR and sequencing primers based on HIV-1 group M sequences. 
Evaluation of the primers using samples collected around the world 
demonstrated broad detection capacity for multiple HIV-1 group subtypes 
and predominant circulating recombinant forms. Further, commercially 
available HIV-1 drug resistance (HIVDR) genotyping assays

[[Page 4737]]

are expensive and have limited ability to detect non-B subtypes. This 
optimized assay is broadly sensitive in genotyping HIV-1 group M viral 
strains and more sensitive than TRUGENE[supreg] and ViroSeq[supreg] 
assays in detecting mixed viral populations. Additionally, this assay 
is useful in resource-limited settings where HIVDR surveillance is 
recommended to minimize the development and transmission of HIVDR.
    Potential Commercial Applications:
     HIV-1 sub-typing diagnostic
     Evaluation of efficacy of anti-HIV therapeutics
     HIV drug resistance (HIVDR) surveillance and monitoring
    Competitive Advantages:
     Cost-effective
     Simple to implement
     Rapid, accurate and objectively conclusive
     Easily implemented as a kit
     Assay could be applicable to HIVDR genotyping in both ART-
naive and ART-experienced populations
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Nicholas Wagar, Chunfu Yang, Zhiyong Zhou, Joshua DeVos 
(all of CDC)
    Publications:
    1. Zhou Z, et al. Optimization of a low cost and broadly sensitive 
genotyping assay for HIV-1 drug resistance surveillance and monitoring 
in resource-limited settings. PLoS One. 2011;6(11):e28184. [PMID 
22132237]
    2. Yang C, et al. Development and application of a broadly 
sensitive dried-blood-spot-based genotyping assay for global 
surveillance of HIV-1 drug resistance. J Clin Microbiol. 2010 
Sep;48(9):3158-64. [PMID 20660209]
    Intellectual Property: HHS Reference No. E-259-2013/0--
     PCT Application No. PCT/US2012/045523 filed 05 Jul 2012, 
which published as WO 2013/006684 on 10 Jan 2013
     US Patent Application No. 14/125,564 filed 11 Dec 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov
    Collaborative Research Opportunity: The Centers for Disease Control 
and Prevention (CDC) is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize Real-time PCR Assay for Detection of 
Pneumococcal DNA and Diagnosis of Pneumococcal Disease. For 
collaboration opportunities, please contact Suzanne Shope at 
sshope@cdc.gov or 770-488-8613.

Intranasal Dry Powder Inhaler for Improved Delivery of Vaccines and 
Therapeutics

    Description of Technology: This Intranasal Dry Powder Inhaler 
(DPI), developed with Creare, Inc., allows low-cost delivery of powder 
vaccines. Nasal delivery has numerous advantages compared to 
traditional injected vaccines, including: (1) Safe, needle-less 
administration by minimally-trained staff or patient; (2) better 
protection due to mucosal and cross-protection; and (3) decreased 
biohazard waste. Further, dry powder aerosol vaccine delivery is 
superior to liquid aerosol delivery in a number of ways, including: (1) 
No dose reconstitution required; (2) highly thermostable and may not 
need cold chain storage; (3) costs less to store and transport; (4) 
improved efficacy through elimination of liquid spray nasal-dripping. 
This CDC-Creare invention is unique in that it is inexpensive and 
suitable for single-use applications, such as vaccination. It prevents 
the dose being deposited within the lower respiratory tract, improving 
safety. This delivery system has a broad range of potential 
applications including, but not limited to, childhood vaccination 
programs, self-administered therapeutics, and emergency biodefense.
    Potential Commercial Applications:
     Intranasal delivery of vaccines and therapeutics
     Childhood vaccination programs, mass immunization 
campaigns, or response to epidemics
    Competitive Advantages:
     Safe, needle-less delivery
     Allows self-administration
     Improved protection via intranasal immunization
     Decreased biohazard waste
     Dose reconstitution is not required
     Highly thermostable and may not need cold chain storage
     Cost-effective
     Primate study with a thermostable measles vaccine expected 
in the next year
    Development Stage:
     In vitro data available
     Prototype
    Inventors: Mark J. Papania, James J. Barry, Darin A. Knaus, Edward 
Moynihan, Eric M. Friets, Mark C. Bagley (all of CDC)
    Intellectual Property: HHS Reference No. E-258-2013/0--
     US Provisional Patent Application No. 61/665,778 filed 28 
Jun 2012
     PCT Application No. PCT/US2013/047399 filed 24 Jun 2013, 
which published as WO 2014/004400 on 03 Jan 2014
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Recombinant Pan-Lyssavirus for Use in Rabies and Broad-Lyssavirus 
Vaccination

    Description of Technology: CDC researchers have developed 
recombinant lyssaviruses that can be used for the development of an 
improved, broad-spectrum vaccine against several rabies genotypes. 
Lyssaviruses are single-stranded RNA viruses that cause rabies and 
rabies-like diseases in mammals. Currently, there are commercially 
available vaccines that are considered to be effective against 
infections from a single viral phylogroup; however, these vaccines 
confer little or no protection against viruses outside of the 
phylogroup. The present recombinants have glycoprotein-encoding genes 
from at least two different lyssaviruses and can be used as pan-
lyssaviral vaccines to provide protection against infection by multiple 
lyssavirus phylogroups.
    Potential Commercial Applications:
     Pan-lyssavirus vaccines
     Rabies surveillance and vaccination programs
    Competitive Advantages:
     Broad-spectrum vaccine potential
     Pan-lyssavirus vaccination tools will be particularly 
beneficial in endemic and developing regions
     Employs a presently commercialized vaccine backbone/
platform, making this innovation easily adaptable for industrial R&D 
and subsequent large-scale production
    Development Stage: Pre-clinical
    Inventors: Xianfu Wu, Charles E. Rupprecht, Ivan V. Kuzmin (all of 
CDC)
    Publication: Kuzmin IV, et al. Complete genomes of Aravan, Khujand, 
Irkut and West Caucasian bat viruses, with special attention to the 
polymerase gene and non-coding regions. Virus Res. 2008 Sep;136(1-
2):81-90. [PMID 18514350]
    Intellectual Property: HHS Reference No. E-256-2013/0--
     PCT Application No. PCT/US2011/041579 filed 23 June 2011, 
which published as WO 2011/163446 on 29 Dec 2011
     US Patent Application No. 13/806,622 filed 21 Dec 2012
    Related Technologies: HHS Reference No. E-326-2013/0--
     PCT Application No. PCT/US2006/040134 filed 13 Oct 2006, 
which published as WO 2007/047459 on 26 Apr 2007
     US Patent No. 7,863,041 issued 04 Jan 2011
     Various international patent applications pending or 
issued

[[Page 4738]]

    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Real-Time PCR Assay for Detection of Pneumococcal DNA and Diagnosis of 
Pneumococcal Disease

    Description of Technology: CDC scientists have developed a real-
time PCR assay for diagnosing pneumococcal disease using amplification 
of the bacterial gene encoding pneumococcal surface adhesin A (PsaA). 
Pneumococcal isolation and identification is often complicated by (1) 
antimicrobial suppression of growth in culture and (2) contamination by 
normal flora alpha-streptococci. Further, pneumococcal detection by 
culture and serological methods can be time-consuming, relatively 
expensive, laborious and, ultimately, indeterminate. Sensitive and 
specific assays that can be completed quickly in the clinical 
laboratory are essential for early diagnosis and effective therapy. 
This RT-PCR assay provides a tool for quick and accurate diagnosis by 
physicians and health care technicians and may be useful in evaluating 
the efficacy of novel pneumococcal vaccines and therapeutics.
    Potential Commercial Applications:
     Pneumococcal disease diagnostics and surveillance programs
     Streptococcus pneumoniae vaccine development and 
improvement
     Evaluation of efficacy of anti-pneumococcal therapeutics
    Competitive Advantages:
     Cost-effective
     Simple to implement
     Rapid, accurate and objectively conclusive
     Easily implemented as a kit
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Jacquelyn S. Sampson, Edwin W. Ades, George Carlone, 
Maria da Gloria Carvalho, Karen McCaustland (all of CDC)
    Publication: Carvalho MG, et al. Evaluation and improvement of 
real-time PCR assays targeting lytA, ply, and psaA genes for detection 
of pneumococcal DNA. J Clin Microbiol. 2007 Aug;45(8):2460-6. [PMID 
17537936]
    Intellectual Property: HHS Reference No. E-250-2013/0--
     PCT Application No. PCT/US2005/010449 filed 28 Mar 2005, 
which published as WO 2006/104486 on 05 Oct 2006
     US Patent No. 7,476,733 issued 13 Jan 2009
     Various international filings issued or pending
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov
    Collaborative Research Opportunity: The Centers for Disease Control 
and Prevention (CDC) is seeking statements of capability or interest 
from parties interested in collaborative research to further develop, 
evaluate or commercialize Real-time PCR Assay for Detection of 
Pneumococcal DNA and Diagnosis of Pneumococcal Disease. For 
collaboration opportunities, please contact Suzanne Shope at 
sshope@cdc.gov or 770-488-8613.

T24 Antigen for Diagnosing or Treating Taenia solium Cysticercosis

    Description of Technology: In order to develop a simple detection 
assay for field use, CDC researchers cloned and sequenced the Taenia 
solium T24 diagnostic protein. The T24 sequences can be used to detect 
and diagnose T. solium infection or can be formulated into a 
pharmaceutical composition. T. solium is a species of tapeworm. 
Intestinal infection with T. solium is referred to as taeniasis. Many 
taeniasis infections are asymptomatic but may be characterized by 
insomnia, anorexia, abdominal pain and weight loss. Cysticercosis 
infection, which can be fatal, may develop if T. solium larvae migrate 
out of the intestine and form cysticerci in various body tissues. This 
technology may be used to develop a diagnostic, vaccine, or therapeutic 
for infection related to T. solium.
    Potential Commercial Applications:
     Vaccine or therapeutic for taeniasis or cysticercosis 
resulting from T. solium infection
     Diagnosis of T. solium infection
     Zoonotic disease research and surveillance
     Public health monitoring programs
     Livestock health and food-source monitoring
    Competitive Advantages:
     Rapid, accurate, sensitive, and safe compared to current 
radiologic and biopsy diagnostic methods
     Easy-to-use diagnostic kit that doesn't require abnormal 
temperatures or specialized equipment
     Can be developed for serologic and/or nucleic acid 
diagnostics
     Cost-effective; useful for developing countries
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Kathy Hancock, Fatima Williams, Melinda L. Yushak, 
Sowmya Pattabhi, Victor C. Tsang (all of CDC)
    Intellectual Property: HHS Reference No. E-237-2013/0--
     US Patent No. 7,547,762 issued 16 Jun 2009
     US Patent No. 7,972,606 issued 05 Jul 2011
    Related Technologies: HHS Reference No. E-247-2013/0--US Patent No. 
6,379,906 issued 30 Apr 2002
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

HIV-1 Multi-Clade, Multivalent Recombinant Vaccine Construct

    Description of Technology: CDC scientists developed immunogenic 
multi-clade, multivalent (HIV1MCMV) recombinant constructs for use as 
HIV-1 vaccines. These polypeptides include immunogenic CTL, T- and/or 
B-cell determinants that are capable of eliciting broad and effective 
immune responses against diverse subtypes of HIV-1. It is believed that 
these HIV-1 constructs provide universal vaccines, capable of effective 
use in any part of the world affected by the HIV-1 epidemic. The 
construct contains specific cellular targeting epitopes that allow 
optimized antigen processing and recognition, and the design of the 
construct allows for the addition or deletion of epitopes. 
Additionally, the construct may be used to develop multi-pathogen 
vaccines by combination with other epitope-based constructs.
    Potential Commercial Applications: Development of HIV-1 vaccine
    Competitive Advantages:
     Allows easy epitope-tailoring
     Broad spectrum protection against HIV-1
     Unlike other HIV-vaccination strategies, this approach 
specifically primes both arms of the immune system for improved 
protection
     Can be combined with other epitope-based constructs to 
generate multi-pathogen vaccines
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Renu B. Lal and Sherry B. Owen (CDC)
    Intellectual Property: HHS Reference No. E-231-2013/0--
     PCT Application No. PCT/US2004/009767 filed 26 Mar 2004, 
which published as WO 2004/085466 on 27 Oct 2004
     US Patent No. 7,425,611 issued 26 Mar 2004
     Various international patent applications pending or 
issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Monoclonal Antibodies for Detection of Stachybotrys chartarum Fungi

    Description of Technology: This invention provides monoclonal

[[Page 4739]]

antibodies that can be used to rapidly and accurately test for the 
presence of Stachybotrys chartarum fungi. Certain fungi found in indoor 
environments, including homes and businesses, may cause adverse health 
effects in people and animals by causing infection or provoking 
allergic reactions. Sick building syndrome, an occupational condition 
in which workers are sickened by environmental toxins or pathogens, has 
been associated with the fungus S. chartarum. The antibodies disclosed 
may be used to identify and detect the presence of S. chartarum in a 
biological sample or a sample obtained from the environment. The 
antibodies may be part of kits to assess human exposure to this fungi 
and they may be useful for improving occupational health.
    Potential Commercial Applications:
     Clinical diagnosis of S. chartarum exposure
     Detection of fungal antigens in biological samples or the 
environment
     Occupational health and home safety
    Competitive Advantages:
     Simple, rapid, and specific detection of S. chartarum 
pathogen
     Easily adaptable for kit format
     Less labor-intensive than spore counts or culturing
     More sensitive than chromatographic detection of 
mycotoxins
     Ensures objective output by directly quantifying spores 
rather than relying on genetically influenced molecular markers or 
sample extraction techniques
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Detlef Schmechel and Daniel M. Lewis (CDC)
    Intellectual Property: HHS Reference No. E-224-2013/0--US Patent 
No. 7,368,256 issued 06 May 2008
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Real-Time PCR for Detecting Legionella Species and Discriminating 
Legionella pneumophila

    Description of Technology: Legionella pneumophila is the causative 
species in most cases of Legionnaires' disease (LD). CDC scientists 
have developed a real-time PCR assay capable of detecting all 
Legionella species and discriminating L. pneumophila from other 
Legionella species. LD is typically difficult to diagnose from a 
clinical standpoint as it confers no unique clinical features or 
symptoms. This assay provides a rapid and accurate alternative to 
laborious PCR assays, prone to aberrant results. It provides a 
sensitive alternative for diagnosis of Legionnaires' disease and 
detection of L. pneumophila.
    Potential Commercial Applications:
     Diagnostic for Legionnaires' disease
     Detection of all Legionella species and specific 
discrimination of L. pneumophila
    Competitive Advantages:
     Faster than immunoassays
     Less laborious than current LD diagnostics
     Rapid, sensitive, and specific
     Curtails misdiagnoses associated with serological 
evaluations
     Easily adaptable to kit form
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Robert F. Benson, Brian F. Holloway, Karen A. 
McCaustland, Patrick G. Yant (all of CDC)
    Publication: Yang G, et al. Dual detection of Legionella 
pneumophila and Legionella species by real-time PCR targeting the 23S-
5S rRNA gene spacer region. Clin Microbiol Infect. 2010 Mar;16(3):255-
61. [PMID 19438641]
    Intellectual Property: HHS Reference No. E-194-2013/0--
     PCT Application No. PCT/US2009/068461 filed 17 Dec 2009, 
which published as WO 2010/080493 on 15 Jul 2010
     US Patent Application No. 13/140,922 filed 20 Jun 2011
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Real-Time PCR Assays for Selective Detection and Differentiation of B. 
pertussis, B. parapertussis and B. homesii

    Description of Technology: CDC researchers developed a real-time 
PCR assay targeting insertion sequence (IS481) and pertussis toxin 
subunit 1 (ptxS1) of Bordetella pertussis. This real-time nucleic acid 
assay offers rapid, sensitive, and quantitative results. The employed 
primers have been validated through extensive diagnostic testing of 41 
Bordetella and 64 non-Bordetella clinical isolates. This technology can 
be used to diagnose and distinguish B. pertussis, B. parapertussis and 
B. homesii, the three most common Bordetella human upper respiratory 
pathogens. A standalone assay or multi-faceted kit may be used.
    Potential Commercial Applications:
     Diagnostics for Bordetella pathogens
     Investigation of acute upper respiratory illness and 
outbreaks
    Competitive Advantages:
     Validated for the three major pathogens responsible for 
Bordetella-related upper respiratory infections
     Rapid, sensitive and quantitative
     Easily adapted to kit form
     Useful as an added, internal control for present 
Bordetella pertussis diagnostics
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Kathleen M. Tatti, Kansas Sparks, Maria-Lucia C. 
Tondella (all of CDC)
    Publication: Tatti KM, et al. Development and evaluation of dual-
target real-time polymerase chain reaction assays to detect Bordetella 
spp. Diagn Microbiol Infect Dis. 2008 Jul;61(3):264-72. [PMID 18440175]
    Intellectual Property: HHS Reference No. E-193-2013/0--
     PCT Application No. PCT/US2010/032408 filed 26 Apr 2010, 
which published as WO 2010/124281 on 28 Oct 2010
     US Patent Application No. 13/266,099 filed 26 Apr 2010
     Various international patents pending or deferred
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Antigen-Capture Electrochemiluminescent Assay for Determining Rabies 
Vaccine Potency

    Description of Technology: CDC researchers developed a more 
efficient method of assessing rabies vaccine potency using an antigen-
capture electrochemiluminescent (ECL) assay. This assay utilizes SULFO-
NHS-Ester labeled murine monoclonal antibodies to quantify glycoprotein 
concentration, which is an indicator of vaccine potency. Currently, the 
potency of rabies vaccines is determined by the effective-dose (ED50) 
mouse study evaluation method, which is more than 50 years old. The 
labor-intensive ED50 evaluation method has high operating costs, 
extensive biosafety requirements, and requires the sacrifice of a large 
number of animals. CDC researchers have addressed these issues by 
developing a competitive in vitro antigen-capture assay that is rapid, 
highly robust, reproducible, flexible and much less expensive to 
implement than the traditional ED50-mouse study evaluation.
    Potential Commercial Applications:
     Rabies vaccine design and development
     Vaccine quality control and quality assurance testing
     In vitro assay for rabies virus glycoprotein
    Competitive Advantages:
     Efficient vaccine evaluation
     Highly robust, reproducible and flexible

[[Page 4740]]

     Easily standardized for consistent, universal usage and 
assurance of batch-to-batch vaccine homogeneity
     In vitro assay may replace the 50 year old ED50 mouse 
procedure
    Development Stage:
     Pre-clinical
     In vitro data available
     In vivo data available (animal)
    Inventors: Todd G. Smith and Charles E. Rupprecht (CDC)
    Publication: Smith TG, et al. An electrochemiluminescence assay for 
analysis of rabies virus glycoprotein content in rabies vaccines. 
Vaccine. 2013 Jul 18;31(33):3333-8. [PMID 23742991]
    Intellectual Property: HHS Reference No. E-180-2013/0--
     US Provisional Patent Application No. 61/713,130 filed 12 
Oct 2012
     PCT Application No. PCT/US2013/064911 filed 15 Oct 2013
    Related Technologies:
     HHS Reference No. E-256-2013/0--
--US Patent Application No. 13/806,622 filed 21 Dec 2012
--PCT Application No. PCT/US2011/041579 filed 23 June 2011, which 
published as WO 2011/163446 on 29 Dec 2011
     HHS Reference No. E-326-2013/0--
--PCT Application No. PCT/US2006/040134 filed 13 Oct 2006, which 
published as WO 2007/047459 on 26 Apr 2007
--US Patent No. 7,863,041 issued 04 Jan 2011
--US Patent Application No. 12/956,949 filed 30 Nov 2010
--Various international patent applications pending or issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Isolated Lyssavirus Nucleic Acid and Protein Sequences

    Description of Technology: A novel strain in the rabies family of 
viruses, the Shimoni bat virus (SHIBV), has been discovered. Phylogenic 
and antigenic patterns identify SHIBV as a new species of Lyssavirus. 
Phylogenic reconstructions of SHIBV and monoclonal antibody typing were 
used to demonstrate a distinct genetic antigenic pattern. This unique 
genetic information may be used to create antigens or vaccines against 
SHIBV and provides opportunity for the development of new diagnostics, 
therapeutics, and prophylactic therapies for viral infection.
    Potential Commercial Applications:
     Vaccines, therapies or diagnostics for Shimoni bat virus
     Rabies epidemiology and surveillance
     Lyssavirus/rabies research tool
    Competitive Advantages:
     Protects against phylogroup II lyssaviruses, unlike 
current commercially available rabies vaccines
     Isolated biomaterials provide novel lyssavirus research 
tools
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Ivan V. Kuzmin (CDC), Charles E. Rupprecht (CDC), et al.
    Publications:
    1. Kuzmin IV, et al. Shimoni bat virus, a new representative of the 
Lyssavirus genus. Virus Res. 2010 May;149(2):197-210. [PMID 20138934]
    2. Kuzmin IV, et al. Commerson's leaf-nosed bat (Hipposideros 
commersoni) is the likely reservoir of Shimoni bat virus. Vector Borne 
Zoonotic Dis. 2011 Nov;11(11):1465-70. [PMID 21867415]
    Intellectual Property: HHS Reference No. E-179-2013/0--PCT 
Application No. PCT/US2011/021309 filed 14 Jan 2011, which published as 
WO 2013/081571 on 17 Oct 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Real-Time TaqMan RT-PCR Assays for Selective Detection of Human 
Rhinovirus

    Description of Technology: This invention relates to selective 
detection of human rhinovirus (HRV) in biological media. Specifically, 
this invention discloses a real-time TaqMan RT-PCR assay targeting the 
5'-noncoding region of the HRV genome. This is a one-step, real-time 
nucleic acid assay that offers rapid, sensitive, and quantitative 
results. The assay is validated against all 100 recognized HRV 
prototype strains.
    HRV is the most frequent cause of the common cold. From a clinical 
standpoint, diagnosis of HRV infection is quite difficult as the 
related symptoms can be caused by other agents as well. Additionally, 
laboratory detection of HRV is challenging as HRV exhibits extreme 
antigenic variability and certain strains cannot be maintained by cell 
culture.
    Potential Commercial Applications:
     Development of human rhinovirus (HRV) diagnostics
     Acute lower respiratory illness diagnostics and 
investigation
    Competitive Advantages:
     Validated against all 100 human rhinovirus prototype 
strains
     Rapid, sensitive and quantitative
     One-step assay
     Easily adapted to kit form
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Xiaoyan Lu and Dean D. Erdman (CDC)
    Publication: Lu X, et al. Real-time reverse transcription-PCR assay 
for comprehensive detection of human rhinoviruses. J Clin Microbiol. 
2008 Feb;46(2):533-9. [PMID 18057136]
    Intellectual Property: HHS Reference No. E-177-2013/0--US Patent 
Application No. 12/315,758 filed 05 Dec 2008
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Composition and Methods for Rapid Detection of HIV by Loop-Mediated 
Isothermal Amplification

    Description of Technology: This invention relates to methods and 
compositions for rapid detection of HIV nucleic acids in a biological 
sample. Specifically, it involves the use of the loop-mediated 
isothermal amplification (LAMP) for rapid detection of HIV-1 and/or 
HIV-2. The use of rapid HIV tests is highly attractive for screening of 
patient samples, especially in developing countries where resources are 
limited, because they are quick, easy to perform, and do not require 
any special equipment. Rapid tests for the identification of HIV 
antibody, however, will remain negative during the 4 to 5 week window 
post-infection and pre-seroconversion, necessitating the need for a 
diagnosis based on HIV nucleic acid.
    Potential Commercial Applications:
     Diagnostic test for HIV-1 and/or HIV-2 infection
     Kits for detection of HIV nucleic acids
    Competitive Advantages:
     High sensitivity and specificity
     No need for thermal cyclers or gel electrophoresis
     Assay can be used in limited-resource settings
     Rapid, portable and cost-effective alternative to PCR and 
enzyme immune assays
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Michele S. Owen, Kelly Curtis, Donna L. Rudolph (all of 
CDC)
    Publications:
    1. Curtis KA, et al. Isothermal amplification using a chemical 
heating device for point-of-care detection of HIV-1. PLoS One. 
2012;7(2):e31432. [PMID 22384022]
    2. Curtis KA, et al. Sequence-specific detection method for reverse 
transcription, loop-mediated isothermal amplification of HIV-1. J Med 
Virol.

[[Page 4741]]

2009 Jun;81(6):966-72. [PMID 19382260]
    3. Curtis KA, et al. Rapid detection of HIV-1 by reverse-
transcription, loop-mediated isothermal amplification (RT-LAMP). J 
Virol Methods. 2008 Aug;151(2):264-70. [PMID 18524393]
    Intellectual Property: HHS Reference No. E-173-2013/0--
     PCT Application No. PCT/US09/035130 filed 25 Feb 2009, 
which published as WO 2009/108693 on 03 Sep 2009
     US Patent Application No. 12/918,536 filed 20 Aug 2010
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Autocidal Gravid Ovitrap Mosquito Trap for Control and Surveillance of 
Mosquitoes

    Description of Technology: Mosquitoes are responsible for the 
transmission of a number of important zoonotic diseases, including 
dengue fever, malaria, and rift valley fever. The CDC-AGO (Autocidal 
Gravid Ovitrap) mosquito trap is a device that targets older female 
mosquitoes looking for a suitable place to lay eggs. This device is 45 
centimeters tall with a 10-liter capacity to hold an attractant, such 
as water and decaying vegetation. The mosquitoes are captured by a 
nontoxic adhesive and eggs are collected on a hydrogel. The use of the 
hydrogel instead of a liquid prevents the larvae from hatched mosquito 
eggs from completing development.
    Novel aspects of this technology are the use of non-toxic 
components and slow to dry hydrogel, as opposed to insecticide. While 
there are a number of chemical methods for controlling mosquitoes, 
these chemicals are always subject to the evolution of resistance from 
the mosquito population and, thus, there is a need for additional non-
chemical control methods.
    Potential Commercial Applications:
     Device for mosquito control
     May be useful in regions of the world affected by vector-
borne zoonotic diseases, such as dengue fever, malaria, Rift Valley 
fever or West Nile virus
    Competitive Advantages:
     Many ovitraps are short-lived as insecticide compound 
degrades over time and/or mosquito population becomes insecticide-
resistant
     Utilizes a nontoxic adhesive and hydrogel polymer, as 
opposed to insecticide
    Development Stage:
     Prototype
     In vitro data available
    Inventors: Roberto Barrera, Andrew J. Mackay, Manuel Amador (all of 
CDC)
    Publications:
    1. Barrera, R. et al. 2010. ``Field Trials of a New Gravid-ovitrap 
for Integrated Area-wide Control of Aedes Aegypti in Puerto Rico.'' In 
Abstract Book, 83 (5 Supplement):179. The American Journal of Tropical 
Medicine and Hygiene. Atlanta, GA, USA. [https://www.astmh.org/Meeting_Archives.htm]
    2. Mackay AJ, et al. An improved autocidal gravid ovitrap for the 
control and surveillance of Aedes aegypti. Parasit Vectors. 2013 Aug 
6;6(1):225. [PMID 23919568]
    Intellectual Property: HHS Reference No. E-166-2013/0--
     PCT Application No. PCT/US2012/025462 filed 16 Feb 2012, 
which published as WO 2012/112785 on 23 Aug 2012
     U.S. Patent Application No. 13/822,598 filed 12 Mar 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

sodC-Based Real-Time PCR Assay for Detection of Neisseria meningitidis 
Infection

    Description of Technology: CDC researchers have developed a real-
time PCR assay for the detection of Neisseria meningitidis sodC within 
clinical specimens. The ability to detect all strains of N. 
meningitidis, regardless of individual serogroup, is the central 
innovation of this technology. Further, the assay is sensitive enough 
to detect even the very limited sample sizes of N. meningitidis that 
would typically be found in clinical specimens. This technology avoids 
potentially catastrophic false-negative results associated with current 
N. meningitidis carriage study testing methods. At least 16% of carried 
N. meningitidis lacks the ctrA gene, which is the current target of 
serogroup-based real-time PCR. N. meningitidis is the etiologic agent 
of epidemic bacterial meningitis and sepsis throughout the world and 
rapid detection of N. meningitidis infection is essential for patient 
well-being.
    Potential Commercial Applications:
     Routine N. meningitis surveillance, especially useful in 
carriage studies
     Rapid, specific identification of N. meningitis infection
    Competitive Advantages:
     Rapid, sensitive and specific
     Present culture detection methods are limited by low 
sensitivity and long incubation periods; this assay demonstrates 
improved detection of meningococci, regardless of encapsulation status 
or bacteria viability
     Circumvents ctrA-based testing-related false negative 
results in carriage studies
     No further technical development needed for 
commercialization
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Jennifer D. Thomas, Cynthia P. Hatcher, Raydel D. Mair, 
Mary J. Theodore (all of CDC)
    Publication: Dolan TJ, et al. sodC-based real-time PCR for 
detection of Neisseria meningitidis. PLoS One. 2011 May 5;6(5):e19361. 
[PMID 21573213]
    Intellectual Property: HHS Reference No. E-165-2013/0--
     PCT Application No. PCT/US2011/055784 filed 11 Oct 2011, 
which published as WO 2012/048339 on 12 Apr 2012
     US Patent Application No. 13/816,903 filed 03 Apr 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Real-Time PCR Assay for Specific Detection of Haemophilus influenzae 
Serotypes A and B

    Description of Technology: Haemophilus influenzae is responsible 
for life-threatening respiratory infections including meningitis. This 
assay allows for the qualitative detection of the bacterial meningitis 
pathogen H. influenzae serotype A (Hia) and serotype B (Hib) in fluid 
samples, without detecting any of the other serotypes of H. influenzae. 
This invention is capable of detecting even the very small numbers of 
Hia or Hib within clinical specimens.
    Potential Commercial Applications:
     Meningitis nucleic acid-based diagnostics for testing 
clinical samples
     Useful for public health monitoring programs
     Surveillance of circulating H. influenzae serotypes
    Competitive Advantages:
     Easily adapted to a real-time PCR assay (monoplex or 
multiplex) kit
     Rapid, accurate and specific, especially when compared to 
sero-diagnostic approaches
     No further testing need, presently ready for 
commercialization
    Development Stage:
     Early-stage
     Pre-clinical
     In vitro data available
    Inventors: Jennifer D. Thomas, Xin Wang, Cynthia P. Hatcher, Raydel 
Anderson, Mary J. Theodore, Leonard W. Mayer (all of CDC)
    Intellectual Property: HHS Reference No. E-164-2013/0--
     PCT Application No. PCT/US2012/022753 filed 26 Jan 2012, 
which published as WO 2012/103353 on 02 Aug 2012

[[Page 4742]]

     U.S. Patent Application No. 13/996,913 filed 21 Jun 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Rapid Detection of Multi-Drug-Resistant Mycobacterium tuberculosis 
Using Real-Time PCR and High-Resolution Melt Analysis

    Description of Technology: CDC scientists have developed a rapid, 
sensitive, and specific real-time PCR assay that is capable of 
detecting the presence of Mycobacterium tuberculosis and determining 
its resistance profile to antibiotics, such as rifampicin and 
isoniazid. Currently, there are few assays available that are capable 
of both detecting M. tuberculosis and determining the bacteria's drug 
resistance. This assay incorporates multiple fluorescent chemistries, 
providing a simple and cost-effective method of determining the 
bacteria's drug resistance. Additionally, this assay may be used to 
quickly discriminate Mycobacterium tuberculosis complex (MTBC) strains 
from non-MTBC strains.
    Potential Commercial Applications:
     Rapid screening of potential multi-drug-resistant M. 
tuberculosis
     Kits for diagnosis of M. tuberculosis
     Public health programs combating emerging drug-resistance 
in M. tuberculosis; clinics working with at-risk populations
    Competitive Advantages:
     Robust and inexpensive way to detect dominant M. 
tuberculosis mutations
     Rapid results within 5 hours of obtaining DNA
     More cost-efficient and less complex than culturing and 
sequencing methods of determining drug-resistant status
    Development Status:
     Early-stage
     In vitro data available
    Inventors: James E. Posey, Jonas M. Winchell, Kelley Cowart, 
Melissa Ramirez (all of CDC)
    Publication: Ramirez MV, et al. Rapid detection of multidrug-
resistant Mycobacterium tuberculosis by use of real-time PCR and high-
resolution melt analysis. J Clin Microbiol. 2010 Nov;48(11):4003-9. 
[PMID 20810777]
    Intellectual Property: HHS Reference No. E-160-2013/0--
     PCT Application No. PCT/US2011/035217 filed 04 May 2011, 
which published as WO 2011/140237 on 10 Nov 2011
     US Patent Application No. 13/695,935 filed 02 Nov 2012
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Linear Epitopes of Anthrax Toxin Protective Antigen for Development of 
a Peptide Vaccine

    Description of Technology: Bacillus anthracis is a gram-positive, 
spore-forming bacteria that causes anthrax infection in humans. CDC 
inventors have identified epitope sequences of B. anthracis protective 
antigen (PA) that may be useful for development of peptide-based 
anthrax vaccines. This invention also relates to methods for 
determining whether post-vaccination protection is achieved. 
Specifically, this invention relates to a screening method for 
determining protection against B. anthracis infection that involves 
testing a biological sample for the presence of antibodies to one or 
more predefined regions of B. anthracis PA. This technology may be 
important to any bioterrorism defense strategy.
    Potential Commercial Applications:
     Novel anthrax vaccines
     Post-vaccination screening to determine if anthrax 
protection is achieved
     Biodefense
    Competitive Advantages:
     May require fewer vaccination follow-ups, while present 
anthrax vaccines require numerous rounds of injections and boosters for 
full-effectiveness
     Identified peptide sequences, representing regions of PA, 
elicit an immune response in primate and human sera studies
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Vera A. Semenova, Conrad P. Quinn, Jan Pohl, Pavel 
Svoboda (all of CDC)
    Intellectual Property: HHS Reference No. E-158-2013/2--
     PCT Application No. PCT/US2011/024317 filed 10 Feb 2011, 
which published as WO 2011/100408 on 18 Aug 2011
     US Patent Application No. 13/577,878 filed 08 Aug 2012
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Multiplex Assay for Detection of Dengue Virus

    Description of Technology: Dengue virus (DENV) is the cause of 
dengue illness (dengue fever, dengue hemorrhagic fever, and dengue 
shock syndrome). CDC researchers have developed a RT-PCR multiplex 
assay that, prior to sero-conversion, selectively detects dengue virus 
in biological or other fluid media, such as whole blood, plasma, or 
serum. The primers and probes from this assay are sufficiently specific 
to amplify and detect all four DENV serotypes. This FDA-approved 
technology may provide an improved method for rapid and accurate 
serotyping of dengue virus in clinical and research settings.
    Potential Commercial Applications:
     Rapid, simple and accurate dengue virus (DENV) serotype 
identification
     Diagnostic tool for clinical or research settings
    Competitive Advantages:
     Increased sensitivity and efficiency compared to current 
antigen-based assays and single reaction real-time RT-PCR analyses
     Addresses need for accurate molecular diagnosis of DENV
     FDA approved technology
    Development Stage:
     In vitro data available
     In situ data available (on-site)
    Inventors: Jorge L. Munoz-Jordan, Edgardo Vergne-Maldonado, 
Gilberto A. Santiago (all of CDC)
    Publications:
    1. Munoz-Jordan JL, et al. Genetic relatedness of dengue viruses in 
Key West, Florida, USA, 2009-2010. Emerg Infect Dis. 2013 
Apr;19(4):652-4. [PMID 23632064]
    2. Santiago GA, et al. Analytical and clinical performance of the 
CDC real time RT-PCR assay for detection and typing of dengue virus. 
PLoS Negl Trop Dis. 2013 Jul 11;7(7):e2311. [PMID 23875046]
    Intellectual Property: HHS Reference No. E-148-2013/0--PCT 
Application No. PCT/US2012/061828 filed 25 Oct 2012, which published as 
WO 2013/066705 on 10 May 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Use of Vitronectin as a Biomarker for the Detection of Dengue 
Hemorrhagic Fever

    Description of Technology: Dengue hemorrhagic fever (DHF) is a 
severe, potentially deadly infection spread by mosquitos. CDC 
scientists have identified vitronectin as an important biomarker of 
DHF. They have shown vitronectin is significantly reduced in DHF and 
severe dengue infections when compared to dengue non-hemorrhagic fever 
patients. Presently, DHF is established by assessing antibody 
concentrations and other rule-of-thumb criteria, but often these assays 
can be difficult to interpret and lead to false conclusions. 
Establishing vitronectin levels provides a specific, novel biomarker 
for DHF, leading to increased accuracy in clinical diagnoses and 
improved patient outcomes.

[[Page 4743]]

    Potential Commercial Applications:
     Diagnostic biomarker of DHF
     Point-of-care diagnostic testing
     Enzyme-linked immunosorbent assay (ELISA) for clinical and 
laboratory use
    Competitive Advantages:
     While there are commercially-available ELISAs to detect 
vitronectin, these products have not been used for dengue diagnosis
     Vitronectin assessment assays provide a novel, specific 
biomarker for the DHF disease state
     Easily developed for serologic diagnostic assays
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Elizabeth Hunsperger (CDC), Momar Ndao (McGill 
University), Kay Tomashek (CDC), Betty Poole-Smith (CDC)
    Publication: Poole-Smith BK, et al. Discovery and Validation of 
Prognostic Biomarkers for Severe Dengue by Proteomic Screening. 
International Conference on Emerging Infectious Diseases 2012: poster 
and oral presentation abstracts. Emerg Infect Dis. 2012 Mar. [https://wwwnc.cdc.gov/eid/pdfs/ICEID2012.pdf ]
    Intellectual Property: HHS Reference No. E-147-2013/0--
     PCT Application No. PCT/US2012/025472 filed 16 Feb 2012, 
which published as WO 2013/130029 on 06 Sep 2013
     US Patent Application No. 13/985,507 filed 14 Aug 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Real-Time RT-PCR Assay for Detection of Noroviruses

    Description of Technology: A specific and sensitive TaqMan-based 
real-time (rt) RT-PCR assay has been developed by CDC scientists for 
detection of noroviruses in clinical and environmental specimens. This 
assay can be implemented to rapidly detect and distinguish norovirus 
strains from genogroups I and II, which are responsible for the 
majority of human infections. Additionally, the assay is multiplexed 
with an internal extraction control virus (coliphage MS2) to validate 
the results of the assay. Since the virus cannot be grown in cell 
culture and enzyme immunoassays lack the necessary sensitivity, this 
technology is particularly useful.
    Potential Commercial Applications:
     Development of norovirus diagnostics
     Specific rtRT-PCR assay for detecting and distinguishing 
of the major pathogenic norovirus genogroups (I and II) within clinical 
and environmental samples
    Competitive Advantages:
     This is an internally controlled, multiplexed assay 
capable of rapid, accurate identification of norovirus genogroups 
responsible for human illness
     Superior sensitivity compared with immunoassay detection 
methods
    Development Stage:
     Pre-clinical
     In vitro data available
    Inventors: Jan Vinje, Nicole Gregoricus, Preeti Chhabra, Leslie 
Barclay, Hannah Shirley, David Lee (all of CDC)
    Publications:
    1. Vega E, et al. Novel surveillance network for norovirus 
gastroenteritis outbreaks, United States. Emerg Infect Dis. 2011 
Aug;17(8):1389-95. [PMID 21801614]
    2. Schultz AC, et al. Development and evaluation of novel one-step 
TaqMan realtime RT-PCR assays for the detection and direct genotyping 
of genogroup I and II noroviruses. J Clin Virol. 2011 Mar;50(3):230-4. 
[PMID 21195660]
    Intellectual Property: HHS Reference No. E-145-2013/0--PCT 
Application No. PCT/US2012/065269 filed 15 Nov 2012, which published as 
WO 2013/074785 on 23 May 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

    Dated: January 23, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-01635 Filed 1-28-14; 8:45 am]
BILLING CODE 4140-01-P