Government-Owned Inventions; Availability for Licensing, 7207-7215 [2014-02491]

Agencies

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

[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7207-7215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02491]


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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.

HIV-1 BED: A Simple Serological Assay for Detecting Recent Infection 
and Estimating Incidence of Multiple, Worldwide HIV-1 Subtypes

    Description of Technology: This CDC developed invention is a simple 
enzyme immunoassay that detects increasing levels of anti-HIV-IgG after 
seroconversion and can be used for detection of HIV-1 infection. The 
assay, termed IgG-Capture BED-EIA, incorporates a branched peptide 
derived from 3 different subtypes to allow equivalent detection of 
antibodies of different subtypes. The competitive format of the assay 
allows detection of increasing proportion of HIV-1 IgG for almost 2 
years after seroconversion. This is different from what is normally 
observed in a conventional EIA (with antigen coated plates) that 
plateaus soon after seroconversion. This assay will be important for 
HIV prevention activities, targeting resources, and evaluation of 
ongoing interventions.
    Potential Commercial Applications:

 HIV clinical serodiagnostics
 Informing clinical decision-making
 Public health/HIV monitoring programs and incidence 
surveillance

    Competitive Advantages:

 Ready for commercialization
 Simple and high-throughput capable
 Detects HIV-1 subtypes prevalent in N. America, Europe, Japan, 
Thailand, Australia, and also central and E. Africa

    Development Stage: In vitro data available
    Inventors: Bharat S. Parekh and J. Steven McDougal (CDC)
    Publications:

1. Parekh BS, et al. Determination of mean recency period for 
estimation of HIV type 1 Incidence with the BED-capture EIA in 
persons infected with diverse subtypes. AIDS Res Hum Retroviruses. 
2011 Mar;27(3):265-73. [PMID 20954834]
2. Dobbs T, et al. A comprehensive evaluation of the proficiency 
testing program for the HIV-1 BED incidence assay. J Clin Microbiol. 
2011 Oct;49(10):3470-3. [PMID 21832016]
3. Parekh BS, et al. Quantitative detection of increasing HIV type 1 
antibodies after seroconversion: a simple assay for detecting recent 
HIV infection and estimating incidence. AIDS Res Hum Retroviruses. 
2002 Mar 1;18(4):295-307. [PMID 11860677]
4. Dobbs T, et al. Performance characteristics of the immunoglobulin 
G-capture BED-enzyme immunoassay, an assay to detect recent human 
immunodeficiency virus type 1 seroconversion. J Clin Microbiol. 2004 
Jun;42(6):2623-8. [PMID 15184443]
5. Nesheim S, et al. Temporal trends in HIV Type 1 incidence among 
inner-city childbearing women in Atlanta: use of the IgG-capture 
BED-enzyme immunoassay. AIDS Res Hum Retroviruses. 2005 
Jun;21(6):537-44. [PMID 15989458]

    Intellectual Property: HHS Reference No. E-555-2013/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Related Technologies:
 HHS Reference No. E-357-2013/0--Research Tool. Patent 
protection is not being pursued for this technology.
 HHS Reference No. E-358-2013/0--Research Tool. Patent 
protection is not being pursued for this technology.
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov

Improved Botulism, Botulinum Neurotoxin Type-E Diagnostics

    Description of Technology: CDC researchers have improved upon a 
prior,

[[Page 7208]]

HHS patented mass spectrometry-based Endopep-MS assay that is able to 
rapidly detect and differentiate all seven botulinum neurotoxin (BoNT) 
types A to G. This current improvement comprises the addition of two 
optimized substrate peptides that increases the assay's sensitivity, 
relative to prior substrates, for botulinum neurotoxin type-E (BoNT/E) 
by greater than 100 fold.
    Currently, the primary method of detecting BoNT contamination 
entails mouse lethality bioassays. In addition to the sacrifice of 
numerous animals, these lethality assays are expensive and require 
several days to obtain results. During a suspected BoNT exposure, time 
is of the essence. The previously patented mass spectrometry approach 
can provide diagnostic results for all seven BoNT types in a matter of 
hours, at greater cost-efficiency and without animal toxicity studies. 
The specific innovation builds upon those earlier improvements by 
providing new substrates that allow for tremendous increases in the 
degree of sensitivity for BoNT/E-specific detection within clinical 
samples.
    Potential Commercial Applications:

 Detection of bolulinum neurotoxin type-E (BoNT/E) in clinical 
samples
 Basic research investigating neurotoxin activity, Clostridium 
botulinum and botulism
 Biodefense, biosecurity
 Food safety assurance

    Competitive Advantages:

 More sensitive, greater cost-efficiency and provides results 
significantly faster than traditional BoNT/E mouse lethality assays
 Builds upon a previously established and patented mass 
spectrometry-based Endopep-MS assay, adding optimized peptides that 
improve current BoNT/E detection sensitivity >100 fold

    Development Stage: In vitro data available.
    Inventors: Dongxia Wang, Suzanne R. Kalb, John R. Barr (all of 
CDC).
    Publications:

1. Kalb SR, et al. The use of Endopep-MS for the detection of 
botulinum toxins A, B, E, and F in serum and stool samples. Anal 
Biochem. 2006 Apr 1;351(1):84-92. [PMID 16500606]
2. Boyer AE, et al. From the mouse to the mass spectrometer: 
detection and differentiation of the endoproteinase activities of 
botulinum neurotoxins A-G by mass spectrometry. Anal Chem. 2005 Jul 
1;77(13):3916-24. [PMID 15987092]

    Intellectual Property: HHS Reference No. E-528-2013/0--PCT 
Application No. PCT/US2013/073885 filed 09 Dec 2013.
    Related Technology: HHS Reference No. E-460-2013/0--US Patent No. 
7,611,856 issued 03 Nov 2009.
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Novel One-Well Limiting-Antigen Avidity Enzyme Immunoassay To Detect 
Recent HIV-1 Infection Using a Multi-Subtype Recombinant Protein

    Description of Technology: This CDC developed Limiting-Antigen 
avidity Enzyme Immunoassay (LAg-avidity-EIA) provides an easy way to 
measure increasing binding strength (avidity) of HIV antibodies as part 
of maturation HIV antibodies after seroconversion, providing a method 
to distinguish early-stage from long-term HIV-1 infection. Surveillance 
of HIV-1 provides information on prevalence rates of the disease, but 
determination of new infection rates (HIV-1 incidence) is difficult to 
deduce. Longitudinal follow up is expensive and can be biased.
    Unlike assays which use antigens derived from only one subtype and 
use two wells, this new approach employs a multi-subtype recombinant 
protein, rIDR-M, to permit equivalent detection of antibody avidity 
among different subtypes, and measures binding strength of antibody in 
one well. This assay will allow the simultaneous testing of more 
specimens and better overall reproducibility due to its design. 
Further, the approach is likely to be more robust and provide more 
accurate results. The assay may be used for individual diagnosis of 
recent or long-term infection, but may also act as an important tool 
for worldwide HIV-1 surveillance, assessing new trends of infections, 
and monitoring success of varied and comparable prevention efforts 
implemented by major public health agencies.
    Potential Commercial Applications:

 Population surveillance: estimation of HIV-1 incidence in 
cross-sectional specimens
 Identifying recent infection risk factors
 Following antibody avidity maturation over time

    Competitive Advantages:
 Assay permits equivalent detection of HIV antibody avidity 
among different subtypes
 Design of LAg avidity-EIA allows for testing more samples and 
better reproducibility when compared to two-well avidity index EIA

    Development Stage: In vitro data available.
    Inventor: Bharat S. Parekh (CDC).
    Publications:

1. Duong YT, et al. Detection of recent HIV-1 infection using a new 
limiting-antigen avidity assay: potential for HIV-1 incidence 
estimates and avidity maturation studies. PLoS One. 
2012;7(3):e33328. [PMID 22479384]
2. Wei X, et al. Development of two avidity-based assays to detect 
recent HIV type 1 seroconversion using a multisubtype gp41 
recombinant protein. AIDS Res Hum Retroviruses. 2010 Jan;26(1):61-
71. [PMID 20063992]

    Intellectual Property: HHS Reference No. E-522-2013/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Stable, Early-Stage Biomarker for Diagnosis of Bacillus Anthracis 
Infection and Anthrax Vaccine Development

    Description of Technology: This invention comprises monoclonal 
antibodies, proteins, and related nucleic acid coding sequences that 
identify all or part of the antigenic anthrose oligosaccharide of 
Bacillus anthracis, the causative agent of anthrax toxicity in humans. 
It is imperative to identify virulent B. anthracis with speed and 
specificity, however there presently is substantial difficulty in 
early-stage recognition and diagnosis of anthrax inhalation. Improved 
diagnostic assays that can reliably identify anthrax exposure in its 
earliest stages and distinguish anthrax from other flu-like illnesses 
are sorely needed.
    CDC and collaborative researchers have developed this technology 
and confirmed the value of an anthrose biomarker assay as a potentially 
valuable tool in informing early-stage response decisions following 
potentially anthrax exposure with in vivo primate data. This invention 
may be used for development of point-of-care anthrax exposure tests, as 
well as therapeutics and vaccines directed against B. anthracis.
    Potential Commercial Applications:

 Biodefense, biosecurity
 Point-of-care B. anthracis-exposure diagnostic
 Anthrax vaccine development
 Development of B. anthracis therapeutics

    Competitive Advantages:
 Valuable tools for screening at-risk individuals following 
possible anthrax exposure
 May be developed as a rapid, lateral-flow assay for emergency 
point-of-care diagnosis
 In vivo primate studies validate efficacy as serologic 
biomarker following aerosolized spore exposure

[[Page 7209]]

 Anthrose biomarker assay readout is critically unaffected by 
ciprofloxacin (anti-anthrax) treatment

    Development Stage:

 In vitro data available
 In vivo data available (animal)
    Inventors: Conrad P. Quinn (CDC), Elke Saile (CDC), Geert-Jan Boons 
(Univ of Georgia), Russell Carlson (Univ of Georgia)
    Publication:

Saile E, et al. Antibody responses to a spore carbohydrate antigen 
as a marker of nonfatal inhalation anthrax in rhesus macaques. Clin 
Vaccine Immunol. 2011 May;18(5):743-8. [PMID 21389148]

    Intellectual Property: HHS Reference No. E-474-2013/0--PCT 
Application No. PCT/US2011/021242 filed 14 Jan 2011, which published as 
WO 2011/088288 on 21 Jul 2011

    Related Technologies:

 HHS Reference No. E-158-2013/2
 HHS Reference No. E-167-2013/0
 HHS Reference No. E-196-2013/0
 HHS Reference No. E-203-2013/0
 HHS Reference No. E-210-2013/0

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

Therapeutic, Bifunctional Janus Microparticles With Spatially 
Segregated Surface Proteins and Methods of Production

    Description of Technology: CDC researchers have developed a 
fabrication process to create bifunctional microparticles displaying 
two distinct proteins that are spatially segregated onto a single 
hemispheric surface. At present, there is no described way of producing 
biological microparticles with two distinct types of separated 
proteins. Bifunctional Janus particles generated by the CDC approach 
possess biologically relevant, native conformation proteins attached to 
a biologically unreactive and safe substrate. They also display high 
densities of each type of proteins that may enable a range of 
capabilities that monofunctional particles cannot, such as improved 
drug targeting and bioimaging agents.
    The possible uses of these particles are limited only by the 
biological functions of proteins. For example, two recognition proteins 
could be used to bring different biological effectors together for 
enzymatic activation or breakdown. A recognition protein plus an 
activation molecule could simultaneously bind a cell and stimulate the 
immune system or facilitate the breakdown of toxic products. 
Alternatively, a protein drug plus a targeting and internalization 
motif could target treatment to a specific subset of cells and reduce 
nonspecific effects of drugs with severe side effects. Such 
bifunctional Janus particles can be used to create an entirely novel 
class of smart particle capable of high avidity targeting to and 
stimulation of multiple cell types. With these new particles, 
scientists and biomedical engineers can potentially improve the range, 
specificity and capabilities of therapeutic interventions and research.
    Potential Commercial Applications:

 Development of improved bioimaging agents and approaches for 
basic research and therapeutic use
 Cellular adhesion and uptake promotion
 Innumerable therapeutic and research usages, for example:
    --Microparticle propulsion and targeting: ActA/RGD
    --Nanoparticle Antibiotic: Fc/Ab
    --Targeted cell killing: Fc/RGD
    --Arbitrary linkages: Streptavidin-biotin
    Competitive Advantages:

 Circumvents issue with current bifunctional microparticles 
having low density attachment and being operatively impotent
 Enables a range of capabilities that monofunctional particles 
cannot, such as improved targeting of drugs and bioimaging capabilities
 Provides a dense concentration of antibody binding events to 
create an artificial immunological recognition milieu that will 
overcome immunoevasive or -suppressive strategies, and/or mutations by 
pathogens

    Development Stage: In vitro data available
    Inventors: David White (CDC), Todd Sulchek (Georgia Tech Research 
Corp), Jennifer Tang (Georgia Institute of Technology)
    Publication:

Tang JL, et al. Bifunctional Janus microparticles with spatially 
segregated proteins. Langmuir. 2012 Jul 3;28(26):10033-9. [PMID 
22624704]

    Intellectual Property: HHS Reference No. E-457-2013/0--U.S. Patent 
Application No. 61/815,784 filed 24 May 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov

Recombinant Nucleic-Acid Based Flavivirus Nucleic Acids for Development 
of Vaccines and/or Sero-Diagnostics

    Description of Technology: CDC scientists have developed 
recombinant flavivirus nucleic acids for the generation of broad 
protective immunity against flaviviruses, as well as the development of 
sensitive serologic diagnostic tools. Mosquito borne viral encephalitis 
is often caused by a flavivirus, such as Japanese encephalitis virus, 
dengue virus or West Nile virus. Infection by these pathogens is often 
lethal to both humans and animals.
    Specifically, these novel recombinant nucleic acids encode critical 
structural proteins of flaviviruses, such as yellow fever virus. The 
invention provides for a method of immunizing a subject against 
infection by a number of pathogenic flaviviruses. Furthermore, 
generated antigenic subviral particles can also serve as a tool for the 
development of specific, antibody detection-based flavivirus diagnostic 
assays.
    Potential Commercial Applications:

 Development of a broadly useful commercial vaccine for 
pathogenic flaviviruses
 Insect-borne disease monitoring and surveillance programs
 Generated antigen can be used for high-specificity serologic 
diagnostic assays

    Competitive Advantages:

 In vivo animal studies demonstrate specific antibody 
generation and complete protection
 Desired immune response provided by a single intramuscular 
injection in both murine and equine studies
 Potential for vaccine use and the development of commercial 
flavivirus infection diagnostic assays and kits

    Development Stage:
 In vitro data available
 In vivo data available (animal)

    Inventor: Gwong-Jen J. Chang (CDC)
    Publications:

1. Chang GJ, et al. Flavivirus DNA vaccines: Current status and 
potential. Ann N Y Acad Sci. 2001 Dec;951:272-85. [PMID 11797784]
2. Chang GJ, et al. A single intramuscular injection of recombinant 
plasmid DNA induces protective immunity and prevents Japanese 
encephalitis in mice. J Virol. 2000 May;74(9):4244-52. [PMID 
10756038]

    Intellectual Property: HHS Reference No. E-341-2013/0--

 U.S. Patent No. 7,417,136 issued 26 Aug 2008
 U.S. Patent No. 8,105,609 issued 31 Jan 2012
 U.S. Patent Application No. 13/338,529 filed 28 Dec 2011
 Various international patent applications pending or issued

    Related Technologies: HHS Reference No. E-341-2013/1--

[[Page 7210]]

 U.S. Patent No. 7,227,011 issued 05 Jun 2007
 U.S. Patent No. 7,521,177 issued 21 Apr 2009
 U.S. Patent No. 7,632,510 issued 15 Dec 2009
 U.S. Patent No. 7,662,394 issued 16 Feb 2010
 U.S. Patent No. 8,221,768 issued 17 Jul 2012
 U.S. Patent No. 8,232,379 issued 31 Jul 2012
 Various international patent applications pending or issued

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

Vaccine Attenuation via Deoptimization of Synonymous Codons

    Description of Technology: Research scientists at CDC have 
developed compositions and methods that can be used to develop 
attenuated vaccines having well-defined levels of replicative fitness 
and enhanced genetic stabilities. Infections by intracellular 
pathogens, such as viruses, bacteria, and parasites, are cleared in 
most cases after activation of specific T-cell immune responses that 
recognize foreign antigens and eliminate infected cells. Vaccines 
against those infectious organisms traditionally have been developed by 
administration of whole live attenuated or inactivated microorganisms. 
Although research has been performed using subunit vaccines, the levels 
of cellular immunity induced are usually low and not capable of 
eliciting complete protection against diseases caused by intracellular 
microbes. CDC inventors discovered that replacement of one or more 
natural (or native) codons in a pathogen with synonymous unpreferred 
codons can decrease the replicative fitness of the pathogen, thereby 
attenuating the pathogen. The unpreferred synonymous codon(s) encode 
the same amino acid as the native codon(s), but have nonetheless been 
found to reduce a pathogen's replicative fitness.
    Potential Commercial Applications:

 Vaccine design and development
 Functional improvements for current vaccines
 Increasing the phenotypic stability of live attenuated 
vaccines
 Attenuation optimization endeavors

    Competitive Advantages:

 Retains the protective and immunogenic advantages of native-
codon live attenuated vaccine strains
 Alleviates some critical safety issues associated with using 
live attenuated vaccines
 Likely to possess greater long-term genetic stability than 
single-point mutations (fewer reversions)

    Development Stage: In vitro data available
    Inventors: Olen M. Kew, Cara C. Burns, Raymond Campagnoli, 
Jacqueline Quay, Jing Shaw (all of CDC)
    Publication:

Burns CC, et al. Modulation of poliovirus replicative fitness in 
HeLa cells by deoptimization of synonymous codon usage in the capsid 
region. J Virol. 2006 Apr;80(7):3259-72. [PMID 16537593]

    Intellectual Property: HHS Reference No. E-328-2013/0--

 PCT Application No. PCT/US2005/036241 filed 07 Oct 2005, which 
published as WO 2006/042156 on 20 Apr 2006
 U.S. Patent Application No. 11/576,941 filed 19 Nov 2007
 Various international patent applications pending or issued

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

Photoinduced Electron Transfer Fluorescent Primer for Nucleic Acid 
Amplification

    Description of Technology: CDC scientists have developed a rapid 
and cost-efficient method for generating fluorescently labeled primers 
for PCR and real-time PCR. At present, fluorescent primers are useful 
for detecting and identifying microbes and specific nucleic acid 
sequences, amplifying nucleic acids for pyro-sequencing, determining 
the levels of gene expression, and many other uses. However, problems 
exist with current techniques used to create fluorescent primers. For 
one, labeling is not one hundred percent efficient, leading to 
inaccurate results. Further, it is expensive and time consuming for 
researchers to make and label their own unique primers. This technology 
allows for the creation of custom primers in which fluorescent dye 
attaches to all oligomers.
    This technology employs photoinduced electron transfer (PET) 
nucleic acid molecules that can be used detect and amplify target 
nucleic acid molecules. PET tags are attached to the 5'-end of a 
target-specific oligo for fluorescent labeling of the primer. PET tag 
activity can be quenched by at least two consecutive guanosines (G-G) 
within the tag sequence and activity is un-quenched when the PET tag 
hybridizes with its complementary nucleic acid molecule.
    Potential Commercial Applications:

 Efficient fluorescence-labeling of oligonucleotides
 Quantitative methods
 Pyro-sequencing
 Basic laboratory research

    Competitive Advantages:

 Avoids aberrant quantitative data generation resulting from 
inefficient fluorescent labeling reactions
 Allows for multiplex reactions
 Cost-efficient for time, sample preservation and cost of 
analysis
 Method can readily be used as part of an oligo-labeling kit
 No need for HPLC purification
 Does not require a quencher dye

    Development Stage: In vitro data available
    Inventors: Jothikumar Narayanan, Vincent R. Hill, Brian F. Holloway 
(all of CDC)
    Publication:

Jothikumar N, Hill VR. A novel photoinduced electron transfer (PET) 
primer technique for rapid real-time PCR detection of 
Cryptosporidium spp. Biochem Biophys Res Commun. 2013 Jun 
28;436(2):134-9. [PMID 23727382]

    Intellectual Property: HHS Reference No. E-292-2013/0--

 PCT Application No. PCT/US2008/084347 filed 21 Nov 2008, which 
published as WO 2009/067664 on 28 May 2009
 U.S. Patent Application No. 12/743,607 filed 19 May 2010
 Various international filings pending

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

Virus Replicon Particles as Rift Valley Fever Vaccines

    Description of Technology: Rift Valley fever (RVF) virus primarily 
infects animals but also has the capacity to infect humans. The disease 
causes abortion and death among RVF-infected livestock, resulting in 
substantial economic loss to people living in many parts of Africa and 
Arabian Peninsula. Currently, there is no commercial vaccine for RVF. 
CDC scientists have developed a RVF virus replicon particle (VRP) 
vaccine candidate. Research findings revealed that immunization of mice 
with a single dose of the RVF-VRP was found to be safe and elicited 
immune response that offered 100% protection following exposure to 
lethal dose of virulent virus. RVF-VRPs have the potential to become 
effective and efficient RVF vaccines in livestock animals and humans.
    Potential Commercial Applications:

 Rift Valley fever vaccine for livestock and/or humans
 VRPs may serve as useful laboratory tool to study the basic 
mechanisms of virus replication, assembly, kinetics, and virus 
maturation


[[Page 7211]]


    Competitive Advantages:

 Murine survival study showed single-dose immunization 
completely protected mice against a virulent RVFV challenge at 100,000-
fold greater than the 50% lethal dose (LD(50))
 Rapid onset of a systematic antiviral response suggests 
conference of early protection
 Low genetic diversity for RVF virus indicates a strong 
potential for broad-use effectiveness with this vaccine

    Development Stage:

 In vitro data available

 In vivo data available (animal)

    Inventors: Kimberly Dodd, Cesar G. Albarino, Brian H. Bird, Stuart 
T. Nichol (all of CDC)
    Publication:

Dodd KA, et al. Single-dose immunization with virus replicon 
particles confers rapid robust protection against Rift Valley fever 
virus challenge. J Virol. 2012 Apr;86(8):4204-12. [PMID 22345465]

    Intellectual Property: HHS Reference No. E-272-2013/0--

 U.S. Application No. 61/661,614 filed 19 Jun 2012
 PCT Application No. PCT/US2013/046250 filed 18 Jun 2013, which 
published as WO 2013/192944 on 27 Dec 2013

    Related Technology: HHS Reference No. E-254-2013/2
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov.

Molecular Detection and Viral-Load Quantification for HIV-1 Groups M, N 
and O, and Simian Immunodeficiency Virus-cpz (SIVcpz)

    Description of Technology: This invention provides materials, 
methods, and assays for detecting HIV-1 groups M and O and optionally 
HIV-1 group N and simian immunodeficiency virus-cpz (SIV-cpz). Specific 
nucleic acid primers for hybridization, amplification, and detection of 
HIV-1 are also provided for. The nucleic acid amplification assays can 
detect small concentrations of HIV-1 and are also useful for 
quantitative examinations of viral load concentrations within 
biological samples.
    Potential Commercial Applications:

 Blood and plasma donation screening
 Diagnostic detection of HIV-1
 Public health programs
 Monitoring HIV treatment and disease inhibition/progression

    Competitive Advantages:

 Broad-use, generic viral detection for groups M, N and O HIV-
1, and also SIVcpz
 Requires minute quantities of virus for use, making this assay 
ideal for confirmation of early-stage infection
 Sensitive and highly specific
 Easily formulated for kits
 Established efficacy in patient samples

    Development Stage:

 In vitro data available
 In situ data available (on-site)

    Inventors: Renu B. Lal, Danuta Pieniazek, Chunfu Yang (all of CDC)
    Publication:

Yang C, et al. Detection of diverse variants of human 
immunodeficiency virus-1 groups M, N, and O and simian 
immunodeficiency viruses from chimpanzees by using generic pol and 
env primer pairs. J Infect Dis. 2000 May;181(5):1791-5. [PMID 
10823786]

    Intellectual Property: HHS Reference No. E-271-2013/0--U.S. Patent 
No. 8,575,324 issued 05 Nov 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov

Virus Microneutralization Assay Data Analysis for Vaccine Development, 
Enhancement and Efficacy Improvement

    Description of Technology: This CDC generated invention entails 
improved methods of analyzing microneutralization assays, especially 
for the purposes of determining specific antibody concentrations and 
optimizing vaccine formulation. More specifically, the invention is a 
set of SAS based programs using 4-parameter logistic curve fitting 
algorithms to interpolate between individual data points, allowing for 
enhanced accuracy and precision when establishing neutralization 
titers. This method allows every experiment to be analyzed the same 
way, provides greater accuracy by interpolating curve fits between 
dilutions, prevents transcription errors or manual calculation errors, 
develops and applies consistent quantitative control rules, and 
improves operational speed and efficiency.
    Potential Commercial Applications:

 Commercial virus vaccine evaluation and strain selection
 Virus strain surveillance programs
 Harmonize data analysis and standardize reporting procedures 
for improved worldwide, health-programs cohesion

    Competitive Advantages:

 Demonstrated improvements in accuracy and precision 
calculating virus microneutralization titers
 Programs produce structured datasets allowing for rapid report 
generation and high-level analyses
 Useful for improved strain selection in future influenza (or 
other) vaccine development

    Development Stage:

 In vitro data available
 In situ data available (on-site)

    Inventors: Jarad Schiffer and Kathy Hancock (CDC)
    Publications:

1. Klimov A, et al. Influenza virus titration, antigenic 
characterization, and serological methods for antibody detection. 
Methods Mol Biol. 2012;865:25-51. [PMID 22528152]
2. Vequilla V, et al. Sensitivity and specificity of serologic 
assays for detection of human infection with 2009 pandemic H1N1 
virus in U.S. populations. J Clin Microbiol. 2011 Jun;49(6):2210-5. 
[PMID 21471339]

    Intellectual Property: HHS Reference No. E-262-2013/0--

 PCT Application No. PCT/US2011/041459 filed 22 Jun 2011, which 
published as WO 2011/163370 on 29 Dec 2011
 U.S. Patent Application No. 13/700,978 filed 29 Nov 2012

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

Fluorescent Primer(s) Creation for Nucleic Acid Detection and 
Amplification

    Description of Technology: CDC researchers have developed 
technology that consists of a simple and inexpensive technique for 
creating fluorescent labeled primers for nucleic acid amplification. 
Fluorescent chemical-labeled probes and primers are extensively used in 
clinical and research laboratories for rapid, real-time detection and 
identification of microbes and genetic sequences. During nucleic acid 
amplification, the ``UniFluor'' primer is incorporated into newly 
synthesized double stranded DNA. As a consequence, quenching of the 
dye's fluorescent signal occurs decreasing the fluorescence of the 
sample several fold. The decrease in fluorescence can be measured and 
observed using any commercially available nucleic acid amplification 
system that measures fluorescence (e.g., real-time PCR/thermocyclers). 
Because many real-time PCR applications require a multitude of 
fluorescently labeled primers or probes, the single-labeled primer 
technique also allows researchers and clinicians to perform their work 
at lower cost.
    Potential Commercial Applications:

 Quantitative detection and/or amplification of specified 
nucleic acid sequences
 Efficient fluorescence-labeling of oligonucleotides

[[Page 7212]]

 Pyro-sequencing
 Basic laboratory research

    Competitive Advantages:

 Simple to implement
 Rapid, real-time detection
 Used with standard laboratory equipment capable of monitoring 
fluorescence-intensity shifts
 Cost-effective
 Easily adapted for use in kits or arrays

    Development Stage: In vitro data available
    Inventors: Vincent R. Hill and Jothikumar Narayanan (CDC)
    Intellectual Property: HHS Reference No. E-252-2013/0--

 PCT Application No. PCT/US2006/000175 filed 03 Jan 2006, which 
published as WO 2006/074222 on 13 Jul 2006
 U.S. Patent No. 7,709,626 issued 04 May 2010
 Several international patent applications pending or issued

    Related Technologies:

 HHS Reference No. E-273-2013/0
 HHS Reference No. E-292-2013/0

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

Multi-Antigenic Peptide(s) Vaccine and Immunogen for Conferring 
Streptococcus Pneumoniae Immunity

    Description of Technology: Disease caused by Streptococcus 
pneumoniae (pneumococcus) is an important cause of morbidity and 
mortality in the United States and developing countries. Pneumococcal 
disease is prevalent among the very young, the elderly and 
immunocompromised individuals. This invention is an improved, 
immunogenic peptide construct consisting of a combination of antigenic 
epitopes of the PsaA (37-kDa) protein from S. pneumoniae. In addition, 
the peptides of the invention have the capability of serving as 
specific immunogens in a subject, effectively eliciting the production 
of antibodies and conferring protective immunity against S. pneumoniae 
infection following immunogen administration.
    Potential Commercial Applications:

 Development or improvement of S. pneumoniae vaccines
 Public health vaccination programs
 Clinical serodiagnostic development

    Competitive Advantages:

 May provide better immune protection than current, single-
epitope based vaccines
 Broader spectrum of S. pneumoniae serotypes addressed
 Immunization with these peptides was shown to reduce carriage 
in murine studies

    Development Stage:

 In vitro data available
 In vivo data available (animal)

    Inventors: Edwin W. Ades, George M. Carlone, Jacquelyn S. Sampson, 
Scott E. Johnson, Danny L. Jue (all of CDC)
    Intellectual Property: HHS Reference No. E-248-2013/1--
 PCT Application No. PCT/2001/021626 filed 10 Jul 2001, which 
published as WO 2002/004497 on 17 Jan 2002

 U.S. Patent No. 6,903,184 issued 07 Jun 2005
 U.S. Patent No. 7,501,132 issued 10 Mar 2009
 U.S. Patent No. 8,642,048 issued 04 Feb 2014
 Various international patent applications pending or issued

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

Device To Measure Muscle Contractile-Relaxant and Epithelial 
Bioelectric Responses of Perfused, Intact Tracheal Airways Tissue In 
Vitro

    Description of Technology: CDC and collaborative researchers have 
developed a device allowing for simultaneous measurement of smooth 
muscle contractile/relaxant activity and transepithelial potential 
difference (Vt) [or short circuit currents (Isc)] and resistance (Rt) 
within an intact airway in vitro. Investigation of the underlying 
mechanisms of lung diseases, such as asthma or cystic fibrosis, 
involves understanding the roles of airway smooth muscle and 
epithelium. Smooth muscle is involved in the control of the airway 
diameter; epithelium regulates the ionic composition of the liquid 
lining the airways through electrogenic ion transport and releases 
factors that regulate the ability of smooth muscle to contract.
    This invention allows for the measurement and study of pulmonary 
diseases under conditions retaining normal spatial relationships 
between all the cell types and an unmanipulated/undistorted tracheal 
airway wall. Further, the device permits evaluation of epithelial 
functional integrity using pharmacological techniques. Agents can be 
separately added to the lumen, where they must first cross the 
epithelium to reach the smooth muscle, or to the outside of the airway, 
where there is no hindrance of said agents to the muscle. The invention 
also permits the effective in vitro screening of the effects of agents 
and drugs on airway epithelium and smooth muscle within the same 
preparation.
    Potential Commercial Applications:

 Investigations into physiological mechanisms of airway 
diseases, such as cystic fibrosis and asthma
 Screening of drugs and therapeutic compounds directed to 
complex, multi-tissue type matrices
 Biomedical research exploring pharmacology-physiology 
integration

Competitive Advantages:

 Allows simultaneous measurement of transepithelial potential 
difference, transepithelial resistance, smooth muscle activity and 
changes in tracheal diameter
 In vitro analysis of trachea or tracheal segments retaining 
native, in situ structure
 Pharmacological agents may be added separately to the lumen 
for screening purposes
 First and only such ``single-preparation'' device allowing for 
such broad array of data output

    Development Stage:

 Early-stage
 In vitro data available
 In situ data available (on-site)
 Prototype

    Inventors: Jeffrey S. Fedan (CDC), Yi Jing (CDC), Michael Van Scott 
(East Carolina University)
    Publication:

JIng Y, et. al. Simultaneous measurement of mechanical responses and 
transepithelial potential difference and resistance, in guinea-pig 
isolated, perfused trachea using a novel apparatus: pharmacological 
characterization. Eur J Pharmacol. 2008 Nov 19;598(1-3):98-103. 
[PMID 18835555]

    Intellectual Property: HHS Reference No. E-246-2013/0--U.S. Patent 
No. 7,907,999 issued 15 Mar 2011.
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov

A Bias-Free Sampling and Collection Trap for Resting Mosquitoes

    Description of Technology: This CDC developed collection device is 
a small (approximately 1 cubic foot) open-sided container that attracts 
mosquitoes seeking a daytime resting location. The container is dark-
colored and constructed of molded wood-fiber or recycled, high-density 
plastic. Mosquitoes that enter the dark space of the container are 
aspirated through a battery-powered fan into a collection receptacle. 
The receptacle is especially attractive to Culex and Anopheles 
mosquitos' vectors of West Nile Virus and malaria parasites, 
respectively.
    For research aims, this device avoids the sampling biases 
associated with

[[Page 7213]]

CO2-baited traps (attracting mosquitoes in host-seeking 
mode, about a tenth of the population, and only females) or ovitraps/
gravid traps (attract egg-laying females, again about a tenth of the 
population), making this device superior to other mosquito-sampling 
traps currently in use. Because all adult mosquitoes must find secluded 
locations to rest every day, this device samples all sectors of the 
mosquito population. It also represents a highly effective trap for 
blood-engorged mosquitoes that rarely enter other types of traps.
    Potential Commercial Applications:

 Mosquito sampling for research and epidemiological 
surveillance purposes
 Mosquito control programs
 Ecological and/or population-genetics interests

    Competitive Advantages:

 Receptacle circumvents sampling biases inherent to other 
mosquito traps
 Device is particularly adept at luring Culex and Anopheles 
mosquitoes

    Development Stage: In situ data available (on-site)
    Inventors: Nicholas A. Panella, Rebekah J. Kent, Nicholas Komar 
(all of CDC)
    Publication:

Panella NA, et al. The Centers for Disease Control and Prevention 
resting trap: a novel device for collecting resting mosquitoes. J Am 
Mosq Control Assoc. 2011 Sep;27(3):323-5. [PMID 22017100]

    Intellectual Property: HHS Reference No. E-223-2013/0--U.S. Patent 
Application No. 12/813,279 filed 10 Jun 2010
    Related Technologies:

 HHS Reference No. E-166-2013/0
 HHS Reference No. E-175-2013/0
 HHS Reference No. E-641-2013/0

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

Real-Time PCR Assays for Human Bocavirus Detection and Diagnosis

    Description of Technology: CDC researchers have developed a real-
time PCR assay for the detection and viral-load quantitative 
estimations of human bocavirus (HBoV) from clinical specimens. At 
present, there have been few reports on the epidemiology, geographic 
distribution or clinical features of HBoV infection. Additionally, 
symptoms affiliated with bocavirus infections overlap with numerous 
other respiratory illnesses. This CDC assay provides sensitive, 
specific, and quantitative detection of HBoV in patients with 
respiratory illness by a method of real-time PCR targeting the HBoV NS1 
and NP-1 genes. Use of this assay in conjunction with additional 
diagnostic methods and treatments should facilitate improved diagnosis 
and, subsequently, directed treatment and patient outcome.
    Potential Commercial Applications:

 Human bocavirus (HBoV) research tools
 Respiratory illness diagnostics and research
 Public health surveillance
 Confirmation/diagnosis of HBoV infection

    Competitive Advantages:

 Specific and sensitive
 Capable of rapid HBoV detection and distinction from alternate 
respiratory-illness linked pathogens
 Superior to other HBoV detection methods in cost-efficiency, 
accuracy and quantitation of viral load

    Development Stage: In vitro data available
    Inventors: Dean D. Erdman and Teresa C. Peret (CDC)
    Publication:

Lu X, et al. Real-time PCR assays for detection of bocavirus in 
human specimens. J Clin Microbiol. 2006 Sep;44(9):3231-5. [PMID 
16954253]

    Intellectual Property: HHS Reference No. E-213-2013/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov

Simple, Rapid, and Sensitive Real-Time PCR Assays for Detecting Drug 
Resistance of HIV

    Description of Technology: This novel assay features real-time PCR 
reagents and methods for detecting drug-resistance related mutations in 
HIV, for newly diagnosed patients and those individuals currently 
receiving antiretroviral therapies. As the use of antiretroviral 
compounds to treat HIV infection proliferates, viruses adapt and evolve 
mutations limiting the efficacy of these drugs and disrupting the 
success of treatment. To address this problem, CDC researchers have 
developed this RT-PCR assay, intended for diagnosis of different point 
mutations in patient samples at an achievable sensitivity of 1-2 log 
greater than conventional point-mutation sequencing methods. More 
specifically, this assay measures the differential amplifications of 
common and mutation-specific reactions that target specific codons of 
interest. Given its low cost, simplicity, high-throughput capability, 
and tremendous diagnostic sensitivity, this assay will be useful for 
detection and surveillance of drug resistance-associated mutations and 
will aid in the clinical management of HIV infection.
    Potential Commercial Applications:

 Clinical management of HIV infected patients
 Pre-treatment evaluation baseline HIV infection to tailor 
appropriate drug combinations
 Monitor the spread of resistant viruses
 Blood donation screening
 Research tool to study emergence and biology of drug 
resistance mutations

    Competitive Advantages:

 Cost-effective
 Sensitive and rapid
 Capable of resistance mutation detection in both subtype B and 
non-B subtypes of HIV-1, and in HIV-2
 Easily formatted for use in kits
 High-throughput capable

    Development Stage: In vitro data available
    Inventors: Jeffrey A. Johnson, Walid M. Heneine, Jonathan T. 
Lipscomb (all of CDC)
    Publications:

1. Johnson JA, et al. Simple PCR assays improve the sensitivity of 
HIV-1 subtype B drug resistance testing and allow linking of 
resistance mutations. PLoS One. 2007 Jul 25;2(7):e638. [PMID 
17653265]
2. Johnson JA, et al. Minority HIV-1 drug resistance mutations are 
present in antiretroviral treatment-na[iuml]ve populations and 
associate with reduced treatment efficacy. PLoS Med. 2008 Jul 
29;5(7):e158. [PMID 18666824]
3. Li JF, et al. Detection of low-level K65R variants in nucleoside 
reverse transcriptase inhibitor-naive chronic and acute HIV-1 
subtype C infections. J Infect Dis. 2011 Mar 15;203(6):798-802. 
[PMID 21257741]
4. Nishizawa M, et al. Highly-Sensitive Allele-Specific PCR Testing 
Identifies a Greater Prevalence of Transmitted HIV Drug Resistance 
in Japan. PLoS One. 2013 Dec 16;8(12):e83150. [PMID 24358257]
5. Wei X, et al. Minority HIV mutation detection in dried blood 
spots indicates high specimen integrity and reveals hidden archived 
drug resistance. J Clin Virol. 2011 Feb;50(2):148-52. [PMID 
21130027]
    Intellectual Property:

HHS Reference No. E-198-2013/0--
     PCT Application No. PCT/US2005/019907 filed 07 Jun 2005, 
which published as WO 2005/121379 on 22 Dec 2005
     U.S. Patent No. 8,043,809 issued 25 Oct 2011
     U.S. Patent No. 8,318,428 issued 27 Nov 2012

[[Page 7214]]

     U.S. Patent No. 8,592,146 issued 26 Nov 2013
     U.S. Patent Application No. 14/059,085 filed 21 Oct 2013
     Various international patent applications pending or 
issued
HHS Reference No. E-214-2013/0--
     PCT Application No. PCT/US2012/025638 filed 17 Feb 2012, 
which published as WO 2012/2112884 on 23 Aug 2012
     U.S. Patent Application No. 13/985,499 filed 14 Aug 2013
HHS Reference No. E-511-2013/0--
     U.S. Application No. 61/829,473 filed 31 May 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
whitney.blair@nih.gov

Exposure and Activity Detection Assays for Anthrax Lethal Factor and 
Lethal Toxin

    Description of Technology: This CDC developed invention identifies 
an assay for extremely fast and sensitive detection of Bacillus 
anthracis lethal toxin (LTx), the toxin responsible for the lethal 
effects of anthrax infection. This assay has already been successfully 
tested in animals and will allow for early detection of anthrax 
exposure and screening of lethal factors to monitor anthrax toxicity, 
for example for vaccine trial candidates.
    LTx is composed of two proteins, protective antigen (PA) and lethal 
factor (LF). In one scenario, the assay effectively detects LF by first 
using magnetic protein G beads to capture and concentrate LF in 
samples, then testing for LF on the bead by reacting it with a peptide 
substrate designed to mimic LF's natural target. By using techniques 
such as mass spectrometry, FRET or liquid chromatography, this test can 
check for LF rapidly and with extraordinary specificity and 
sensitivity. Methodology and basic assay validation have been confirmed 
in animals and naturally-exposed (by contaminated meat in a Bangladesh 
processing facility) human serum samples.
    Potential Commercial Applications:

 Emergency anthrax exposure diagnostics
 Testing of and research into anthrax therapeutics, vaccines
 Biodefense, biosecurity
 Livestock health screening

    Competitive Advantages:

 Rapid turnaround
 Highly sensitive-detects picomolar toxin levels
 Reproducible and quantitative anthrax lethal factor (LF) 
assessment
 Easily adaptable for high-throughput screening of numerous 
specimens

    Development Stage:

 In vitro data available
 In vivo data available (animal)
 In vivo data available (human)
 In situ data available (on-site)

    Inventors: Anne E. Boyer, Conrad P. Quinn, John R. Barr (all of 
CDC)
    Publications:

1. Boyer AE, et al. Detection and quantification of anthrax lethal 
factor in serum by mass spectrometry. Anal Chem. 2007 Nov 
15;79(22):8463-70. [PMID 17929949]
2. Boyer AE, et al. Kinetics of lethal factor and poly-D-glutamic 
acid antigenemia during inhalation anthrax in rhesus macaques. 
Infect Immun. 2009 Aug;77(8):3432-41. [PMID 19506008]
3. Kuklenyik Z, et al. Comparison of MALDI-TOF-MS and HPLC-ESI-MS/MS 
for endopeptidase activity-based quantification of Anthrax lethal 
factor in serum. Anal Chem. 2011 Mar 1;83(5):1760-5. [PMID 21302970]
4. Boyer AE, et al. Lethal factor toxemia and anti-protective 
antigen antibody activity in naturally acquired cutaneous anthrax. J 
Infect Dis. 2011 Nov;204(9):1321-7. [PMID 21908727]

    Intellectual Property: HHS Reference No. E-196-2013/0--

 PCT Application No. PCT/US2007/004156 filed 15 Feb 2007, which 
published as WO 2007/136436 on 29 Nov 2007
 U.S. Patent Application No. 11/675,233 filed 15 Feb 2007
 Various international filings pending or issued

    Related Technologies:

 HHS Reference No. E-158-2013/2
 HHS Reference No. E-167-2013/0
 HHS Reference No. E-203-2013/0
 HHS Reference No. E-210-2013/0
 HHS Reference No. E-474-2013/0

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

Select M. Tuberculosis Peptides as Mucosal Vaccines Against Pulmonary 
Tuberculosis

    Description of Technology: This CDC-developed technology relates to 
novel vaccines or boosters directed against pulmonary tuberculosis. 
There is currently only a single vaccine against tuberculosis, the 
(Bacillus Calmette-Gu[eacute]rin) BCG vaccine. Reports suggest widely 
variable effectiveness for the BCG vaccine and that BCG administration 
has very limited success against prevention of the primary pulmonary 
form of the disease. With a marginally useful vaccine and rising rates 
of multidrug-resistant and extensively drug-resistant (MDR and XDR) 
tuberculosis strains, it is clear there is a public health need that 
must be met.
    Researchers working at CDC have developed improved vaccine 
formulations and processes of delivery for enhancing the immune 
response against M. tuberculosis. These improvements may be implemented 
as stand-alone vaccines or in conjunction with BCG as part of a prime-
boost strategy. Intranasal immunization engenders a strong immune 
response in the lungs, which is beneficial because the M. tuberculosis 
pathogen primarily gains entry through the respiratory/alveolar mucosa. 
By specifically stimulating mucosal immunity with select recombinant M. 
tuberculosis polypeptides at the typical site of pathogen entry, it is 
envisioned that these formulations and delivery methods will be able to 
prevent M. tuberculosis infection and subsequent pulmonary tuberculosis 
disease.
    Potential Commercial Applications:

 Tuberculosis vaccine development and improvement
 Public health and BCG vaccination programs

    Competitive Advantages:

 Versatile, has potential as stand-alone vaccine or booster for 
use with current BCG vaccine
 Peptides specifically selected for generating mucosal 
immunity, to address the protective-failings of the BCG vaccine
 Potential for needle-free delivery that elicits robust, well-
directed immune response

    Development Stage:

 In vitro data available
 In vivo data available (animal)

    Inventors: Suraj Sable, et al. (CDC)
    Publication:

Sable SB, et al. Cellular immune responses to nine Mycobacterium 
tuberculosis vaccine candidates following intranasal vaccination. 
PLoS One. 2011;6(7):e22718. [PMID 21799939]

    Intellectual Property: HHS Reference No. E-192-2013/0--
 PCT Application No. PCT/US09/030754 filed 12 Jan 2009, which 
published as WO 2009/089535 on 16 Jul 2009
 U.S. Patent Application No. 12/812,541 filed 08 Oct 2010
 Various international patents issued or pending

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

Detection of Retroviruses and HIV-1 Groups -M and -O Discrimination 
Within Clinical Serum Samples

    Description of Technology: CDC researchers have developed methods 
for

[[Page 7215]]

detecting retroviruses within a patient blood sample and discriminating 
HIV-1 samples within serum specimens. HIV-1 can be genetically 
classified into two major groups, group M (major) and Group O (outlier) 
with group O comprising all divergent viruses that do not cluster with 
group M. The identification of group O infections raised public health 
concerns about the safety of the blood supply because HIV-1 screening 
by group M-based serologic tests does not consistently detect group O 
infection.
    The assay is based on the selective inhibition of Amp-RT reactivity 
of Group M viruses by nevirapine, a non-nucleoside RT inhibitor. Group 
O viruses can be generically identified by the resistance of their Amp-
RT activity to nevirapine. The assay can be used to screening of the 
blood supply and to rapidly differentiate group M from group O virus.
    Potential Commercial Applications:

 Clinical monitoring of individual patient antiretroviral 
therapy
 HIV/AIDS public health programs
 Surveillance of retroviral drug resistance
 Screening of blood donations

    Competitive Advantages:

 Rapid diagnostic which greatly reduces time and labor for 
improved clinical monitoring of HIV treatment
 Ready for commercialization
 Easily adapted to kit format
 Assists continued usefulness of common antiretroviral 
therapeutics
 Useful for high-throughput serum samples screening

    Development Stage: In vitro data available
    Inventors: Thomas M. Folks, Walid Heneine, William Marshall 
Switzer, Shinji Yamamoto (all of CDC)
    Publications:

1. Yamamoto S, et al. Highly sensitive qualitative and quantitative 
detection of reverse transcriptase activity: Optimization, 
validation, and comparative analysis with other detection systems. J 
Virol Methods. 1996 Sep;61(1-2):135-43. [PMID 8882946]
2. Heneine W, et al. Detection of reverse transcriptase by a highly 
sensitive assay in sera from persons infected with human 
immunodeficiency virus type 1. J Infect Dis. 1995 May;171(5):1210-6. 
[PMID 7538549]
3. Reisler RB, et al. Early detection of reverse transcriptase 
activity in plasma of neonates infected with HIV-1: A comparative 
analysis with RNA-based and DNA-based testing using polymerase chain 
reaction. J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):93-102. 
[PMID 11176273]

    Intellectual Property:

HHS Reference No. E-232-1993/0 --
     PCT Application No. PCT/US1996/001257 filed 26 Jan 
1996, which published as WO 1996/023076 on 01 Aug 1996
     Various international patents issued or pending
HHS Reference No. E-232-1993/1--
     U.S. Patent No. 5,849,494 issued 15 Dec 1998
     U.S. Patent No. 6,136,534 issued 24 Oct 2000

    Related Technologies:

HHS Reference No. E-129-2013/0--
     PCT Application No. PCT/US1999/013957 filed 16 Jun 
1999, which published as WO 1999/66068 on 23 Dec 1999
     U.S. Patent No. 6,787,126 issued 07 Sep 2004
     Various international patents issued
HHS Reference No. E-129-2013/1--
     U.S. Patent No. 7,691,572 issued 06 Apr 2010

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

    Dated: January 31, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-02491 Filed 2-5-14; 8:45 am]
BILLING CODE 4140-01-P