Healthcare Industry News:  Prostate Cancer 

Diagnostics Oncology

 News Release - September 10, 2013

Metamark Announces Positive Results of ProMark(TM) Prostate Cancer Clinical Validation Study

Company to Proceed with 2013 Commercial Launch of Novel Prostate Cancer Prognostic Test

CAMBRIDGE, Mass., Sept. 10, 2013 -- (Healthcare Sales & Marketing Network) -- Metamark Genetics, Inc., a privately-held biotechnology company, today announced positive results from a large clinical validation study of ProMark™, its biopsy-based Prostate Cancer prognostic test. The study, conducted in collaboration with Fred Saad, M.D., F.R.C.S., Professor and Chief, Division of Urology, Director of Urologic Oncology, University of Montreal Hospital Center, met its primary endpoint demonstrating that ProMark™, evaluated in standard formalin-fixed, paraffin-embedded prostate tissue, can differentiate indolent from aggressive disease. Based on the results, Metamark plans to make ProMark available to pathologists, urologists and their patients before year-end.

"We are extremely encouraged by the results of this clinical validation study," said Peter Blume-Jensen, M.D., Ph.D., Chief Scientific Officer for Metamark. "More than 85% of Prostate Cancers are detected in men with early-stage disease. Most of these cases are non-aggressive and localized to the prostate gland and thus do not warrant aggressive treatment. Nevertheless, almost 90% receive aggressive therapy, including surgical prostatectomy or radiation, and therefore risk all-too-prevalent side effects such as incontinence and impotence. ProMark was developed to more accurately identify patients with truly indolent disease who may be candidates for active surveillance."

"These are among the most positive clinical validation results I have seen for a Prostate Cancer prognostic test," said Dr. Saad. "It is critical to identify patients whose cancer may be more aggressive than revealed by a needle biopsy. The Metamark test distinguishes those patients with the highest risk cancers from patients with truly indolent disease, and therefore has the potential to be very useful clinically. What is most impressive is the test performs so well as a stand-alone without reliance on other clinical, pathologic or risk stratification models."

Prostate Cancer is one of the most common forms of cancer. Approximately 240,000 cases are expected to be diagnosed in the United States in 2013. Currently, diagnosis and treatment decisions for patients are based primarily on subjective pathological evaluation of prostate biopsies.

Dr. Jonathan Epstein, Professor, Departments of Pathology, Urology, and Oncology, The Reinhard Professor of Urologic Pathology, Director, Surgical Pathology, Johns Hopkins Medical Institution commented that, "The Metamark test clearly outperforms what is currently in practice. A major advantage of the Metamark test is that it can be performed on very small cancers since the test is run labeling tumor on slides, whereas some of the other tests rely on larger amounts of tissue to grind up and analyze."

Metamark's positive, blinded clinical validation study follows three prior studies totaling over 1,250 patient cases, conducted by the Company using its novel, automated, quantitative protein-based multiplex imaging platform.

"I am thrilled about these positive results, which have been critically evaluated by leading Prostate Cancer experts. With our recent acquisition of HealthTronics Laboratory Solutions, a leading provider of urological pathology services, Metamark intends to launch ProMark later this year," said Shawn M. Marcell, President and CEO of Metamark. "We expect ProMark will help patients and physicians make well-informed treatment decisions based on objective, molecular evidence."

About Metamark

Metamark Genetics, Inc. ("Metamark") 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. For more information, please visit the company's Website at Metamark™ and ProMark™ are trademarks of Metamark Genetics, Inc.

Source: Metamark Genetics

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