Metamark Announces Portfolio Expansion To Include PROGENSA® PCA3 And ERG Tests For Assessing Prostate Cancer

CAMBRIDGE, Mass., Sept. 29, 2014 /PRNewswire/ -- Metamark announced today the expansion of its prostate cancer test services to now include the PROGENSA^® PCA3 assay, a urine-based test that can help confirm negative prostate biopsies, and ERG, a companion test to the company's existing PTEN assay. These tests join Metamark's current portfolio, including ProMark™, the only protein-based prognostic test for prostate cancer that will soon be available nationwide. These new options provide patients and their doctors the additional information that can inform a more accurate assessment of their disease, which can lead to better guidance on treatment options.

"With prostate cancer in particular, there is a strong medical need for additional tests to provide men with better information for both screening and the prognosis," said Metamark CEO Shawn Marcell. "Better information leads to improved decision making, and with these new services available from Metamark, it's our hope patients and doctors feel confident in determining the best course of action."

The PROGENSA^® PCA3 assay is the first urine-based molecular test to provide an extra layer of assurance for at-risk men who have already received one or more negative biopsies. The test measures the Prostate Cancer Gene 3, or PCA3, which is expressed 60 to 100 times more often in prostate cancer than in normal cells. A low PCA3 score indicates a decreased likelihood of a positive repeat biopsy result. This ability to improve the diagnosis of prostate cancer can potentially reduce the need for many repeat biopsies. The PROGENSA^® PCA3 assay is provided to Metamark by Hologic.

ERG gene fusion has been noted as an indicator of cancer cell growth, driving the deletion of PTEN, a tumor suppressor gene. In several studies, PTEN loss combined with ERG fusion has been associated with aggressive prostate cancer cells. These indicators are helpful for predicting the likely course of prostate cancer progression. ERG in conjunction with PTEN can be informative in patients who have pre-cancerous conditions or low grade prostate cancer.

"The continued enhancement of our services reinforces Metamark's commitment to the prostate cancer community, with the goal of providing the necessary tools for men to accurately and confidently assess their diagnosis and subsequent treatment options," said Marcell.

Additional information about Metamark's prostate cancer prognostic tests can also be found at www.metamark.us. 

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 options.² 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, such as incontinence and impotence, so addressing this significant overtreatment is critical.

About ProMark^™
ProMark™ is designed to improve the accuracy of prognosis 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 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 1250 patients, with additional prospective studies underway. Metamark plans to commercialize ProMark™ in Q4 2014 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 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 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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SOURCE Metamark