Mitomics Introduces New Test To Detect Prostate Cancer

Mitomics, world leader in the research and development of mitochondrial genome-based products to improve clinical insight and therapeutic decisions, announced today the launch of its flagship product, the Prostate Core Mitomic Testâ„¢ (PCMT), a revolutionary new test that uses the science of mitochondrial DNA (mtDNA) to accurately determine the absence or presence of cancerous cells using previously obtained prostate biopsy tissue. PCMT is available through the company's state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) lab in Aurora, Colo.

"Entering the prostate cancer market is an exciting step forward for our Mitomic Technologyâ„¢ platform and represents the first of several potential markets for us," said Robert Poulter, president and chief executive officer, Mitomics. "In anticipation of this launch, we have been building our U.S. sales team, hiring key members that will support the marketing of PCMT in our initial target markets of Baltimore, Boston, Cleveland, Philadelphia and Chicago. I could not be more proud of the Mitomics team for reaching this important milestone."

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Prostate cancer is the most commonly diagnosed cancer in males and the second leading cause of cancer death in the United States. Every year, more than 230,000 American men are diagnosed with prostate cancer, and about 30,000 die from the disease. If detected early, prostate cancer is often treatable. It is estimated that well over 1 million prostate biopsies are performed annually in the United States, and although approximately 70 percent of all initial prostate biopsies are negative, it has been found that anywhere from 25 to 60 percent of these are positive on second or subsequent biopsy.

Utilizing its cancerization field effect to identify molecular changes and enable detection of missed tumors, PCMT has demonstrated sensitivity of 84 percent and has also been shown to accurately rule out prostate cancer with a negative predictive value of 91 percent. PCMT uses existing prostate biopsy tissue, negating the need for an additional biopsy procedure, and it is performed quickly and easily on the previously obtained sample through a simple lab test.

"With the high rate of false negatives, uncertainty associated with traditional diagnostic tools, whether biochemical or histopathologic, and ongoing controversy regarding treatment paradigms, men at risk for prostate cancer are in need of new options," said Raoul Concepcion, M.D., F.A.C.S., director of clinical research, Urology Associates P.C. in Nashville, Tenn. "The ability of PCMT to use mtDNA to potentially identify malignancy by detecting underlying molecular alterations in normal-appearing tissue is an important advance for managing patients whom the urologist feels may be at increased risk."



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