Mitomics announced the launch of its flagship product, the Prostate Core Mitomic Test, a 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 CLIA (Clinical Laboratory Improvement Amendments) lab in Aurora, CO.

“Entering the prostate cancer market is an exciting step forward for our Mitomic Technology platform and represents the first of several potential markets for us,” said Robert Poulter, president and chief executive officer at Mitomics. “In anticipation of this launch, we have been building our U.S. sales team, hiring key members that will support the marketing of the test 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.”

Utilizing its cancerization field effect to identify molecular changes and enable detection of missed tumors, the Prostate Core Mitomic Test has demonstrated sensitivity of 84% and has also been shown to accurately rule out prostate cancer with a negative predictive value of 91%. The test 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, MD, FACS, director of clinical research, Urology Associates P.C. (Nashville, TN). “The ability of the Prostate Core Mitomic Test 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.”