MDxHealth (R) : MDxHealth Licensee Exact Sciences Receives FDA Approval for its Cologuard Colon Cancer Screening Assay

IRVINE, Calif. , and HERSTAL, Belgium, Aug. 12, 2014 (GLOBE NEWSWIRE) -- MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced that the U.S. Food and Drug Administration's (FDA) has approved Exact Sciences' Cologuard stool-DNA-based, non-invasive colorectal cancer screening test. The test incorporates one of MDxHealth's epigenetic biomarkers, which was licensed to Exact Sciences in July 2010. Upon product launch, anticipated before the end of 2014, MDxHealth expects to receive milestone payments and royalties from the sale of the test under the terms of its licensing agreement.

The FDA approval of Cologuard marks the first stool-based colorectal screening test to earn this designation. Cologuard detects specific changes in a patient's DNA that appear in the stool, which could indicate the presence of colorectal cancer or pre-cancerous polyps. The test also identifies the presence of blood in the stool, another indicator of possible colorectal cancer. Patients with positive test results are advised to undergo a diagnostic colonoscopy.

The Centers for Medicare & Medicaid Services (CMS) has issued a preliminary decision on covering the cost of the test, proposing a three-year testing interval for people ages 50 to 85 with no cancer symptoms. The proposal is subject to a 30-day comment period and final action is expected in November.

About Exact Sciences Corp.

Exact Sciences Corp. is a molecular diagnostics company focused on colorectal cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. Stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please visit the company's website at www.exactsciences.com.

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