Metamark Genetics Receives Laboratory License In Preparation To Launch ProMark™ Prostate-Cancer Assay

Novel Prognostic Test Is Designed to Guide Optimal Decision-Making at Diagnosis

Cambridge, MA /PRNewswire/ - Metamark Genetics, Inc. today announced that its Cambridge, Mass.laboratory has been licensed for the highest level of clinical testing in the use of  ProMark™, the company's prognostic assay to guide the medical management of patients with prostate cancer.

The licensure by the State of Massachusetts for "high-complexity testing" establishes the CLIA-certified laboratory as the national site for processing prostate-tissue samples upon the commercial introduction of ProMark™ planned for early 2014.

The licensure follows the completion last year of a clinical-validation study of ProMark™ that met its primary endpoint in differentiating between aggressive and indolent disease. Altogether, Metamark has completed four clinical studies of ProMark™ comprising 1,275 patients.

Shawn Marcell, President and Chief Executive Officer of Metamark, commented:

"With the licensure of our Cambridge laboratory we have taken another step toward launching ProMark™ so physicians and their patients can use this novel prognostic to address one of the most agonizing questions in men's healthcare—whether a newly diagnosed prostate cancer will spread or whether it will harmlessly remain within the prostate.

"As we prepare to commercialize ProMark™, we are also designing additional clinical studies to further delineate the potential of this new tool to guide the decision whether to treat prostate cancer aggressively or to choose the conservative option of active surveillance.

"We believe the unique format of ProMark™, which enables objective measurement of protein biomarkers in intact prostate tissue, can improve the management of prostate cancer much as other molecular tools have improved the treatment of breast and ovarian cancer."

About prostate cancer

This year some 242,000 men in the United States will be diagnosed with prostate cancer, and many of them will then confront a dilemma. Some prostate tumors are aggressive and life-threatening. Prostate cancer is the second leading cause of cancer deaths among men, after lung cancer, killing about 29,000 men in the United States every year. Yet the majority of prostate tumors are indolent and associated with little risk to health or longevity. The dilemma arises from the difficulty in distinguishing between aggressive and indolent tumors as crucial medical decisions are being made. Aggressive tumors usually necessitate aggressive therapy, most often radical prostatectomy (surgical removal of the entire prostate), sometimes radiation or anti-hormonal treatments. About 87 percent of men, concerned that their tumor will quickly grow and spread, undergo aggressive therapy shortly after diagnosis by needle biopsy (collection of tissue samples for examination).

Aggressive therapy carries serious risks, however, including long-lasting urinary incontinence and sexual dysfunction. More accurate prognosis would better stratify patients by risk of tumor progression, so that men with low-risk profiles could more confidently choose a course of active surveillance through periodic monitoring of tumor status instead of aggressive therapy. In addition, men in need of aggressive therapy can be more confident about receiving appropriate treatment based on a high-risk profile. The need for more accurate prognosis is clearly a prevalent issue in men's healthcare: One in every six men will someday be told that he has prostate cancer.

About ProMark™:

ProMark™ is a proprietary test designed to improve the accuracy of prognosis for men diagnosed with prostate cancer. The test measures the amount of specific protein biomarkers obtained by needle biopsy from regions of prostate tissue where the biomarkers are altered during tumor formation. These "regions of interest" are rendered as intact, paraffin-embedded tissue sections. Quantitative measurements of the biomarkers are then determined by means of imaging technology that is digitized and fully automated. The resulting analysis is thus completely objective and fully reproducible. A large, blinded, clinical-validation study of ProMark™ met its primary endpoint, demonstrating that the test can aid in differentiating between aggressive and indolent disease. The research program supporting ProMark™ has completed four clinical studies altogether, and additional prospective studies are in development or under way. Metamark plans to commercialize ProMark™ in early 2014 through the company's CLIA-certified laboratory in Cambridge, Massachusetts.

About Metamark

Metamark Genetics, Inc. is a privately held biotechnology company founded in 2007 to develop novel, function-based, prognostic and diagnostic tests aimed at improving cancer care. The company's proprietary genomic and proteomic discovery platforms have yielded significant discoveries in several disease areas, including prostate, colon, and breast cancers. Through the acquisition of Healthtronics Laboratory Solutions last year, Metamark has become a leading provider of specialty urological pathology testing services throughout the United States. For more information, please visit the company's Website at www.metamarkgenetics.com. Metamark™ and ProMark™ are trademarks of Metamark Genetics, Inc.