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Public Teleconference Regarding Licensing and Collaborative Research Opportunities for: Diagnostic Tool for Diagnosing Benign Versus Malignant Thyroid Lesions

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

Technology Summary

The technology is an improved method for the detection of thyroid Start Printed Page 65863cancer 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.

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Dated: October 23, 2008.

Richard U. Rodriguez,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. E8-26334 Filed 11-4-08; 8:45 am]

BILLING CODE 4140-01-P