[Federal Register Volume 73, Number 215 (Wednesday, November 5, 2008)]
[Notices]
[Pages 65862-65863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26334]
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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.
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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; [email protected]. 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