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Metamark Introduces Assay That Determines Aggressiveness of Prostate Cancer

by | Feb 23, 2015 | Laboratory Industry Report, Reimbursement-lir

Massachusetts-based Metamark Genetics has released a new molecular-based prostate cancer test that can better pinpoint the overall aggressiveness of the disease. The test, known as the ProMark, is designed for use in prostate cancer patients with Gleason scores in the 3+3 and 3+4 range. Those scores are among the most common for patients diagnosed with […]

Massachusetts-based Metamark Genetics has released a new molecular-based prostate cancer test that can better pinpoint the overall aggressiveness of the disease. The test, known as the ProMark, is designed for use in prostate cancer patients with Gleason scores in the 3+3 and 3+4 range. Those scores are among the most common for patients diagnosed with prostate cancer. Such a score makes it difficult to determine whether the cancer will stay mostly contained in the prostate or will spread to outlying areas. Of the 233,000 or so new cases diagnosed in the United States every year, more than 200,000 have primary Gleason scores in the three range. The five-year survival rate for localized prostate cancer cases is nearly 100 percent, according to data from the National Cancer Institute. In many cases, the cancer can just be regularly monitored without any specific surgical interventions. However, aggressive forms of prostate cancer are entirely different: Survival rates drop below 30 percent once the cancer has spread to other parts of the body. The ProMark test, which retails for $3,800, focuses on levels of protein biomarkers from regions of prostate tissue where the biomarkers have been altered as a result of tumor formation. The tissue can be obtained from a preliminary needle biopsy, and data can be obtained before the patient and their oncologist make any major treatment decisions, company officials said. Metamark is processing the test at its laboratory in Cambridge, Mass. “The ProMark test may provide the health care community with additional information to assist distinguishing indolent from aggressive prostate cancer, thus better informing decisions on an appropriate course of treatment or surveillance,” said Neal D. Shore, M.D., medical director of the Carolina Urologic Research Center in Myrtle Beach, S.C. According to Metamark spokesperson Theresa Dolge, the company estimates that based on clinical validation data, “widespread use of ProMark in the U.S. could help 50,000 to 60,000 patients avoid unnecessary treatment or overtreatment, such as prostatectomies, and allow them to be more confident in pursuing active surveillance as a treatment option. This would result in considerable savings to the health care system based on avoidable treatment costs, as well as reduced morbidities and treatment complications.” Metamark officials said the company would work closely with payers to obtain reimbursement coverage in the near future. It also plans to offer a financial assistance program to patients to manage their out-of-pocket costs for the test, Dolge said. Takeaway: Metamark is attempting to diversify the options available for prostate cancer patients with its new test, potentially avoiding overtreatment and other cost drivers.

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