[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]


-----------------------------------------------------------------------

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; [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