Mitomics enters licensing agreement with QDx Pathology Services for QPredict Prostate Mitomic Test

May 19 2011

Mitomics, world leader in the research and development of mitochondrial genome-based products, today announced it has entered into a non-exclusive licensing agreement with QDx Pathology Services to develop, market and process the QPredict™ Prostate Mitomic Test. The product will be based on the mitochondrial marker behind Mitomics' currently marketed Prostate Core Mitomic Test™ (PCMT™); QDx will leverage its existing network of urologists, pathologists and processing centers to expand the availability of the technology across the United States.

“The urology community has acknowledged there is a clear unmet need for an additional tool to manage the negative biopsy patient”

QDx Pathology Services is a national, independent, full-service clinical and anatomic pathology laboratory dedicated to providing diagnostic excellence. "With its established infrastructure and shared passion and vision for advancing the early detection of prostate cancer, QDx is an excellent partner for Mitomics," said Robert Poulter, president and chief executive officer, Mitomics. "Since the launch of PCMT in late March, our marketing strategy has focused on both direct sales and partnerships to achieve the widest product distribution possible. We look forward to working with our first partner, QDx, to expand awareness even further and ensure our unique testing technology broadly reaches those most in need."

Mitomics' PCMT is a highly advanced test, based on the science of mitochondrial DNA (mtDNA), that accurately determines the absence or presence of cancerous cells using previously obtained prostate biopsy tissue and utilizing its cancerization field effect to identify molecular changes and enable detection of missed tumors. Mitomics' latest research, published in the journal Prostate Cancer and Prostatic Diseases in January 2010, highlights PCMT's sensitivity of 84 percent as well as the test's ability to accurately rule out prostate cancer with a negative predictive value of 91 percent.

M.N. Qureshi, M.D., Ph.D., president and medical director of QDx Pathology commented, "We believe the Mitomic Technology™ is an important piece of the puzzle in detecting prostate cancer in patients with initial negative biopsies. Using existing prostate biopsy tissue, the test negates the need for an additional biopsy procedure and can be performed quickly with rapid turnaround time. We believe that facilitating the early detection of low volume prostate cancer, should, in turn, lead to more definitive treatment."

Mitomics also today provided this update on the launch of PCMT in the United States:

"The urology community has acknowledged there is a clear unmet need for an additional tool to manage the negative biopsy patient," said Chris Merritt, vice president of sales and marketing, Mitomics. "As a result, our direct sales efforts to date have been very successful; we have begun to process tests, report results and continue to receive a favorable response from the market. The early adopters of PCMT are not only valuing the opportunity to know more from their original biopsy cores, but also utilizing the additional clinical data point to make subsequent biopsy decisions with confidence."

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.