CAMBRIDGE, Mass., Aug. 30, 2016 /PRNewswire/ -- Metamark Genetics, Inc., ("Metamark" or the "Company"), a leader in providing critical diagnostic and prognostic information to enable more informed treatment decisions for urological cancer, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses novel molecular diagnostic technologies, has issued final local coverage determination (LCD) for ProMark®, the first and only proteomic prognostic test for early-stage prostate cancer.
The finalized ProMark LCD is effective October 10, 2016, and approves Medicare reimbursement coverage for eligible prostate cancer patients to help determine which patients can be conservatively managed rather than treated with definitive surgery or radiation therapy. The LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website.
"This is a tremendous step for ProMark, opening the door for greater access to essential, decision-making information for prostate cancer patients and their physicians, and enabling more informed and personalized treatment decisions," said Jerry Williamson, president and chief executive officer. "This LCD attests to the growing adoption of ProMark as an important tool in the enhanced care of patients with clinically localized prostate cancer, and strongly supports Metamark's continued commitment to achieving improved outcomes through the availability of better information."
Approximately 200,000 men are diagnosed with prostate cancer each year in the United States, with about 60% of those diagnoses in men over the age of 65.1
ProMark is validated to predict cancer aggressiveness in patients with biopsy Gleason Scores of 3+3 and 3+4, providing a fully independent and individualized prediction that the cancer can be managed without aggressive treatment, or an indication that therapy may be appropriate. The LCD provides coverage to patients with NCCN Very low and Low-risk disease.
1. Prostate Cancer Foundation (www.pcf.org)
Launched in late 2014, ProMark® is the first proteomic classifier of biopsied prostate tissue to assess whether an early-stage prostate tumor is aggressive or indolent. Test results generated in Metamark's Cambridge, Mass. CLIA-certified laboratory can aid the decision whether to treat the cancer aggressively or to choose a course of active surveillance.
Metamark Genetics, Inc. 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 led to significant discoveries in several disease areas, including prostate, bladder, and kidney cancers. Through the acquisition of HealthTronics Laboratory Solutions in 2013, Metamark has become a leading provider of specialty urological pathology testing services with the first fully integrated clinical model for the prostate cancer care pathway.
For more information, please visit the company's website: www.metamarkgenetics.com.
Metamark® and ProMark® are registered trademarks of Metamark Genetics, Inc.
SOURCE Metamark Genetics, Inc.