The Centers for Medicare & Medicaid Services issues a preliminary decision to cover the cost of the test
IRVINE, CA, and HERSTAL, BELGIUM – August 12, 2014 – 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.
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.
MDxHealth is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. The company’s first commercial product, ConfirmMDx® for Prostate Cancer, has been validated to help distinguish patients who have a true-negative biopsy from those who may have undetected cancer, thereby aiding in the reduction of unnecessary repeat biopsies. MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. The company has a proprietary platform and a strong epigenetic product pipeline focused on the development of products for prostate, brain, bladder and lung cancers. For more information visit www.mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
For more information:
|Dr. Jan Groen, CEO||Mike Sinclair|
|US: +1 949 812 6979||UK: +44 20 7318 2955|
|BE: +32 4 364 20 70||Cell: +44 7968 022075|
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.