Metamark Laboratory Received Accreditation from College of American Pathologists

10/9/2014 | Press Release

Cambridge Laboratory Will Serve as Primary Location for Processing ProMark™, the Company’s Newly-Launched Prostate Cancer Prognostic Test

CAMBRIDGE, Massachusetts, December 8, 2014 – Metamark announced today that its laboratory in Cambridge, Massachusetts has received accreditation from the College of American Pathologists (CAP). The Cambridge laboratory will be the primary location for the processing of ProMark™, the newly-launched, first-of-its-kind protein-based biopsy test that helps physicians and their patients with prostate cancer to determine the most appropriate treatment options.

 “Accreditation from CAP is seen as the gold standard in the industry and goes beyond regulatory compliance to ensure that laboratories maintain the highest standards of quality for patient care,” said Anjen Chenn, M.D., Ph.D., Metamark’s senior vice president of clinical operations. “All the procedures and processes we have established for our labs ensure that the results we provide will be accurate and informative to prostate cancer patients as they make important decisions about the treatment of their disease.”

Metamark’s other two Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories – in Collegeville, Pennsylvania and Augusta, Georgia – received CAP reaccreditations earlier this year.

About Prostate Cancer1
A dilemma confronts many of the 233,000 men in the United States who will be diagnosed this year with prostate cancer based on biopsy sampling. Although prostate cancer is a leading cause of cancer deaths among men, killing roughly 29,480 annually, 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, especially for the approximately 205,000 men annually with biopsy Gleason scores of 3+3 and 3+4 who must evaluate their treatment options2. Currently about 87 percent of these men with early stage prostate cancer elect aggressive therapy, although only
3-7 percent progress over lifetime. Aggressive therapy, most often in the form of radical prostatectomy or radiation, has significant side effects, including incontinence and impotence, so addressing this significant overtreatment is critical.

About ProMark™
ProMark™ is a new test that provides an individualized score that helps patients and physicians determine the most appropriate treatment options for men diagnosed with prostate cancer, specifically the approximately 85% of prostate cancer patients with biopsy Gleason grades 3+3 or 3+4 for whom standard-of-care based medical decision making is currently insufficient. 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 fully automated digital imaging technology. The resulting analysis is 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 comprising over 1,250 patients, with additional prospective studies underway. Metamark is commercializing
ProMark through the company's CLIA-certified laboratory in Cambridge, Massachusetts. For more information, visit: www.metamark.us.

About Metamark
Metamark is a privately held biotechnology company founded 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, bladder, 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.metamark.us. Metamark™ and ProMark™ are trademarks of Metamark.


1 National Cancer Institute. Surveillance, Epidemiology, and End Results (SEER) Program. SEER Stat Fact 1 Sheets: Prostate Cancer. http://seer.cancer.gov/statfacts/html/prost.html. Accessed September 2014.

2 Epstein JI, Feng Z, Trock BJ, Pierorazio PM. Upgrading and downgrading of prostate cancer from 2 biopsy to radical prostatectomy: incidence and predictive factors using the modified Gleason grading system and factoring in tertiary grades. European Urology 61(5): 1019-24.

 

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