Optimizing breast cancer therapy strategies

Health Discovery and Smart Personalized Medicine to develop technology for lab tests aimed at personalized breast cancer therapy

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SAVANNAH, Ga.—Health Discovery Corp. (HDC) and Smart Personalized Medicine LLC (SPM) have entered into development and related licensing agreements with Quest Diagnostics Inc., a leading provider of diagnostic testing, information and services.
Under the agreements, Quest Diagnostics will develop new laboratory tests for aiding in the selection of breast cancer therapies based on technology provided by HDC and SPM.
SPM was formed by Dr. Richard E. Caruso, who founded and is now chairman of the board of directors at the billion-dollar health are company, Integra LifeSciences Holdings Corp., to focus on and enable the development of a new method of accomplishing detailed breast cancer patient diagnosis and personalized individual treatment. In 2006, Caruso was named the Ernst & Young National Entrepreneur of the Year for the United States following his founding of Integra LifeSciences.

Health Discovery owns an equity position in Smart Personalized Medicine. In February 2009, Health Discovery announced that it had licensed rights to develop a new urine-based test for clinically significant prostate cancer to Quest.

Under the terms of the agreements, HDC and SPM will receive upfront licensing payments, development fees and royalties on a per-test basis from Quest Diagnostics.

"Richard Caruso has been a long-time supporter of Health Discovery and served on our board," notes HDC chairman and CEO Dr. Stephen D. Barnhill. "We saw an opportunity to deploy our patented Support Vector Machine technologies in the area of breast cancer.  Specifically, we wanted to identify the optimal therapeutic strategies for women diagnosed with breast cancer. We were confident that we had the right partner in Richard Caruso and view the opportunity to work with him as the most expeditious way to apply our technology in this area."

Health Discovery is a molecular diagnostics company that uses advanced mathematical techniques such as Support Vector Machine (SVM) technologies to analyze large amounts of data to uncover patterns that might otherwise be undetectable. It operates primarily in the emerging field of personalized medicine where such tools are critical to scientific discovery. Its primary business consists of licensing its intellectual property and developing its own product line of biomarker-based diagnostic tests that include human genes and genetic variations, as well as gene, protein and metabolic expression differences and image analysis in digital pathology and radiology.

"Our patented-protected technology allows for this kind of discovery," Dr. Barnhill says. "It's been proven in previous test developments, such as our prostate cancer test, that have applied SVMs and RFE-SVMs. We expect to identify a molecular signature in patients that will allow doctors to identify the correct therapy."

RFE-SVM is used to find discriminate relationships within clinical datasets and within gene expression datasets created from microarrays of tumor versus normal tissues. Using the technique, HDC scientists have been able to access specific genetic information that other advanced bioinformatics techniques missed. For example, RFE-SVMs are able to filter irrelevant, tissue-specific genes from those related to malignancy. RFE-SVM also identifies gene expression patterns related to severity of the disease. The data analysis technique provides physicians with patient-specific information and is an enhanced decision-making tool for pharmacogenic and toxicological profiling of the patient.
HDC scientists note that RFE-SVM's analytic methods are effective for finding genes implicated in several cancers.

"In the case of genomic biomarkers," Barnhill notes, "they will sometimes be identifiable in tissue, blood and urine, which is what we discovered with our four-gene biomarker for clinically significant prostate cancer."

In 2009, it is reported that there were approximately 275,000 people in the U.S. and 1.2 million people worldwide diagnosed with breast cancer.

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