Public Teleconference Regarding Licensing and Collaborative Research Opportunities for: Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid Lesions, 65862-65863 [E8-26334]
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Federal Register / Vol. 73, No. 215 / Wednesday, November 5, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel ‘‘SCREENABLE
DISORDERS.’’
Date: December 3, 2008.
Time: 1 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852. (Telephone Conference Call)
Contact Person: Norman Chang, PhD,
Scientific Review Administrator, Division of
Scientific Review, National Institute of Child
Health and Human Development, NIH, 6100
Executive Blvd., Room 5B01, Bethesda, MD
20892, (301) 496–1485,
changn@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel, Innovations in
Lower Limb Prostheses Attachment (RO1).
Date: December 2, 2008.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852. (Telephone Conference Call).
Contact Person: Anne Krey, PhD, Scientific
Review Administrator, Division of Scientific
Review, National Institute of Child Health
and Human Development, National Institutes
of Health, Bethesda, MD 20892, 301–435–
6908.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: October 28, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–26341 Filed 11–4–08; 8:45 am]
Dated: October 29, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–26337 Filed 11–4–08; 8:45 am]
National Institutes of Health
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel, Behavioral Research
Training in Intellectual/Developmental
Disabilities.
Date: November 17, 2008.
Time: 11:45 a.m. to 12:45 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Room 5B01, Rockville,
MD 20852. (Telephone Conference Call)
Contact Person: Carla T. Walls, PhD,
Scientific Review Administrator, Division of
Scientific Review, National Institute of Child
Health and Human Development, NIH, 6100
Executive Blvd., Room 5B01, Bethesda, MD
20892, (301) 435–6898, wallsc@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: October 28, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–26342 Filed 11–4–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Teleconference Regarding
Licensing and Collaborative Research
Opportunities for: Diagnostic Tool for
Diagnosing Benign Versus Malignant
Thyroid Lesions
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
hsrobinson on PROD1PC76 with NOTICES
AGENCY:
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
VerDate Aug<31>2005
17:24 Nov 04, 2008
Jkt 217001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Technology Summary
The technology is an improved
method for the detection of thyroid
E:\FR\FM\05NON1.SGM
05NON1
Federal Register / Vol. 73, No. 215 / Wednesday, November 5, 2008 / Notices
cancer using fine needle aspiration
(FNA) biopsy. It makes use of gene
expression profiles and/or their proteins
to distinguish accurately malignant
thyroid nodules from benign nodules.
This technique exhibits superior
accuracy to current cytology-based FNA
diagnosis. This improved diagnostic
also has potential use for the staging and
treatment of thyroid cancer, a disease
that disproportionately afflicts women.
hsrobinson on PROD1PC76 with NOTICES
Competitive Advantage of Our
Technology
The identification of markers that can
determine a specific type of tumor,
predict patient outcome or the tumor
response to specific therapies is
currently a major focus of cancer
research. The use of gene profiles to
detect thyroid malignancy has the
advantage that it complements the
current method of diagnosis using FNA,
but greatly increases the accuracy of
detecting malignant thyroid lesions.
Technology Description
This technology is based on the
discovery of differentially expressed
thyroid (DET) genes and their encoded
proteins whose expression levels can be
correlated to benign or malignant states
in a thyroid cell. Specifically, this data
arose from a microarray analysis of
genes expressed in the eight subtypes of
thyroid tumors that are typically
difficult to diagnose by cytology of fine
needle aspiration (FNA) biopsies.
Analysis of the (DET) genes led to the
development of a 6 gene and 10 gene
model that distinguishes benign vs.
malignant papillary thyroid tumors.
Subsequently, a 72 gene model has been
developed for diagnosing less common
forms of thyroid cancer like follicular
carcinoma and others. These results
provide a molecular classification
system for thyroid tumors and this in
turn provides a more accurate
diagnostic tool for the clinician
managing patients with suspicious
thyroid lesions.
The invention employs analysis of
DET genes (C21orf4, Hs.145049,
Hs.296031, KIT, LSM7, SYNGR2,
C11orf8, CDH1, FAM13A1, IMPACT,
and KIAA1128) using microarrays or
quantitative RT–PCR (qRT–PCR) to
distinguish between malignant and
benign tumors. For qRT–PCR, primer
and probe sequences were designed to
amplify the six genes or ten genes that
constitute the model. Other means of
detection may also be used such as in
situ hybridization, Northern blot,
Western blot, and
immunocytochemistry. In addition to
diagnostics, this invention can be used
in the staging of thyroid malignancies
VerDate Aug<31>2005
17:24 Nov 04, 2008
Jkt 217001
by measuring changes in DET gene and
protein expression relative to reference
cells. Finally, this invention can also be
used in the discovery of therapeutic
agents through the detection of changes
in DET gene and protein levels prior to
and after treatment.
Market
In 2008, it is expected that about
37,340 new cases of thyroid cancer will
be diagnosed in the United States.
Women will be disproportionately
affected constituting 76% of these new
cases. In contrast to other adult cancers,
thyroid cancer mainly affects younger
people with nearly 2 out of 3 cases
found in patients between the ages of 20
and 55. Fortunately, this is one of the
least deadly cancers; the percentage of
people living at least 5 years after being
diagnosed is about 97%.
Although thyroid cancer is one of the
most curable cancers, current methods
of diagnosis are inaccurate. Thyroid
cancer usually presents itself as nodules
or lumps on the lobes of the gland. The
development of nodules is common
with increasing age; however, most
nodules are usually benign. To
distinguish benign from malignant
nodules, a biopsy is performed using
fine-needle aspiration biopsy (FNA).
Then this sample is examined for
cytological features associated with
cancer. However, cancer is clearly
diagnosed in only 5% of FNA biopsies.
Many biopsy results are inconclusive
and labeled as suspicious or
indeterminate because of difficulties in
distinguishing benign and malignant
thyroid tumors solely on cellular
features. This result greatly impacts
treatment decisions because patients
with benign nodules may be subjected
to unnecessary surgery that will impact
their lives considerably. Thus, there is
a compelling need to develop more
accurate diagnostic tests to detect
thyroid cancer.
Patent Estate
This technology consists of the
following patent applications:
I. United States Patent Application
No. 11/547,995 entitled ‘‘Diagnostic
Tool for Diagnosing Benign Versus
Malignant Thyroid Lesions’’ filed
October 10, 2004 (HHS Ref. No. E–124–
2004/2–US–03); Pre-Grant Publication
No. 2008–0145841.
II. European Patent Application No.
05735973.9 entitled ‘‘Diagnostic Tool
for Diagnosing Benign Versus Malignant
Thyroid Lesions’’ filed April 11, 2005
(HHS Ref. No. E–124–2004/2–PCT–01);
WO publication No. WO/2005/100608.
III. PCT Application No. PCT/
US2008/10139 entitled ‘‘Diagnostic Tool
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
65863
for Diagnosing Benign Versus Malignant
Thyroid Lesions’’ filed August 27, 2008
(HHS Ref. No. E–326–2007/0–PCT–01).
Next Step: Teleconference
There will be a teleconference where
the principal investigator will explain
this technology. Licensing and
collaborative research opportunities will
also be discussed. If you are interested
in participating in this teleconference
please call or e-mail Mojdeh Bahar;
(301) 435–2950; baharm@mail.nih.gov.
OTT will then e-mail you the date, time
and number for the teleconference.
Dated: October 23, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–26334 Filed 11–4–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Research
Resources; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Research Resources Special Emphasis Panel,
STRB SEP.
Date: November 12, 2008.
Time: 3 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892. (Telephone
Conference Call).
Contact Person: Martha F. Matocha, PhD,
Scientific Review Officer, Office of Review,
National Center for Research Resources,
National Institutes of Health, 6701
Democracy Blvd., 1 Democracy Plaza, Rm.
1070, Bethesda, MD 20892, 301–435–0810,
matocham@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
E:\FR\FM\05NON1.SGM
05NON1
]]>Agencies
[Federal Register Volume 73, Number 215 (Wednesday, November 5, 2008)]
[Notices]
[Pages 65862-65863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26334]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Public Teleconference Regarding Licensing and Collaborative
Research Opportunities for: Diagnostic Tool for Diagnosing Benign
Versus Malignant Thyroid Lesions
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
Technology Summary
The technology is an improved method for the detection of thyroid
[[Page 65863]]
cancer using fine needle aspiration (FNA) biopsy. It makes use of gene
expression profiles and/or their proteins to distinguish accurately
malignant thyroid nodules from benign nodules. This technique exhibits
superior accuracy to current cytology-based FNA diagnosis. This
improved diagnostic also has potential use for the staging and
treatment of thyroid cancer, a disease that disproportionately afflicts
women.
Competitive Advantage of Our Technology
The identification of markers that can determine a specific type of
tumor, predict patient outcome or the tumor response to specific
therapies is currently a major focus of cancer research. The use of
gene profiles to detect thyroid malignancy has the advantage that it
complements the current method of diagnosis using FNA, but greatly
increases the accuracy of detecting malignant thyroid lesions.
Technology Description
This technology is based on the discovery of differentially
expressed thyroid (DET) genes and their encoded proteins whose
expression levels can be correlated to benign or malignant states in a
thyroid cell. Specifically, this data arose from a microarray analysis
of genes expressed in the eight subtypes of thyroid tumors that are
typically difficult to diagnose by cytology of fine needle aspiration
(FNA) biopsies. Analysis of the (DET) genes led to the development of a
6 gene and 10 gene model that distinguishes benign vs. malignant
papillary thyroid tumors. Subsequently, a 72 gene model has been
developed for diagnosing less common forms of thyroid cancer like
follicular carcinoma and others. These results provide a molecular
classification system for thyroid tumors and this in turn provides a
more accurate diagnostic tool for the clinician managing patients with
suspicious thyroid lesions.
The invention employs analysis of DET genes (C21orf4, Hs.145049,
Hs.296031, KIT, LSM7, SYNGR2, C11orf8, CDH1, FAM13A1, IMPACT, and
KIAA1128) using microarrays or quantitative RT-PCR (qRT-PCR) to
distinguish between malignant and benign tumors. For qRT-PCR, primer
and probe sequences were designed to amplify the six genes or ten genes
that constitute the model. Other means of detection may also be used
such as in situ hybridization, Northern blot, Western blot, and
immunocytochemistry. In addition to diagnostics, this invention can be
used in the staging of thyroid malignancies by measuring changes in DET
gene and protein expression relative to reference cells. Finally, this
invention can also be used in the discovery of therapeutic agents
through the detection of changes in DET gene and protein levels prior
to and after treatment.
Market
In 2008, it is expected that about 37,340 new cases of thyroid
cancer will be diagnosed in the United States. Women will be
disproportionately affected constituting 76% of these new cases. In
contrast to other adult cancers, thyroid cancer mainly affects younger
people with nearly 2 out of 3 cases found in patients between the ages
of 20 and 55. Fortunately, this is one of the least deadly cancers; the
percentage of people living at least 5 years after being diagnosed is
about 97%.
Although thyroid cancer is one of the most curable cancers, current
methods of diagnosis are inaccurate. Thyroid cancer usually presents
itself as nodules or lumps on the lobes of the gland. The development
of nodules is common with increasing age; however, most nodules are
usually benign. To distinguish benign from malignant nodules, a biopsy
is performed using fine-needle aspiration biopsy (FNA). Then this
sample is examined for cytological features associated with cancer.
However, cancer is clearly diagnosed in only 5% of FNA biopsies. Many
biopsy results are inconclusive and labeled as suspicious or
indeterminate because of difficulties in distinguishing benign and
malignant thyroid tumors solely on cellular features. This result
greatly impacts treatment decisions because patients with benign
nodules may be subjected to unnecessary surgery that will impact their
lives considerably. Thus, there is a compelling need to develop more
accurate diagnostic tests to detect thyroid cancer.
Patent Estate
This technology consists of the following patent applications:
I. United States Patent Application No. 11/547,995 entitled
``Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid
Lesions'' filed October 10, 2004 (HHS Ref. No. E-124-2004/2-US-03);
Pre-Grant Publication No. 2008-0145841.
II. European Patent Application No. 05735973.9 entitled
``Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid
Lesions'' filed April 11, 2005 (HHS Ref. No. E-124-2004/2-PCT-01); WO
publication No. WO/2005/100608.
III. PCT Application No. PCT/US2008/10139 entitled ``Diagnostic
Tool for Diagnosing Benign Versus Malignant Thyroid Lesions'' filed
August 27, 2008 (HHS Ref. No. E-326-2007/0-PCT-01).
Next Step: Teleconference
There will be a teleconference where the principal investigator
will explain this technology. Licensing and collaborative research
opportunities will also be discussed. If you are interested in
participating in this teleconference please call or e-mail Mojdeh
Bahar; (301) 435-2950; baharm@mail.nih.gov. OTT will then e-mail you
the date, time and number for the teleconference.
Dated: October 23, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-26334 Filed 11-4-08; 8:45 am]
BILLING CODE 4140-01-P
