MDxHealth SA, a leading molecular diagnostic company that develops and commercializes epigenetic tests to improve the diagnosis and treatment of cancer patients, today announced that the Molecular and Clinical Genetics Panel of the United States Food and Drug Administration's (FDA) Medical Devices Advisory Committee strongly endorsed approval of Cologuard™. The Committee determined by a unanimous vote of 10 to zero that Exact Sciences has demonstrated safety, effectiveness and a favorable risk benefit profile of Cologuard, the company's stool-based DNA (sDNA), non-invasive colorectal cancer screening test. Cologuard incorporates one of MDxHealth's epigenetic biomarkers and methylation specific PCR (MSP) technology, which was licensed to Exact Sciences in July 2010.
"Colorectal cancer is the second leading cause of cancer death in the United States yet often viewed as the most preventable," stated Dr. Jan Groen, CEO of MDxHealth. "We are very proud to see that one of our epigenetic biomarkers is a key component of the biomarker panel incorporated in the Cologuard screening test."
Cologuard is designed to detect 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.
"We are pleased the Committee strongly supported Cologuard's approval," said Kevin T. Conroy, chairman and chief executive of Exact Sciences. "We look forward to continuing our work with the FDA to complete its review of Cologuard and remain committed to addressing the growing unmet needs in colorectal cancer screening. We thank the FDA and its advisory committee for its careful consideration of Cologuard. We also appreciate the opportunity to participate in the innovative FDA/CMS parallel review program."
Cologuard is an investigational device currently under review by the U.S. Food and Drug Administration (FDA) and is not available for sale in the United States. The Committee's recommendation will be taken into consideration by the FDA in its final review of the Cologuard test. The FDA is not bound by the Committee's guidance but often follows this expert guidance.
MDxHealth (mdxhealth.com) 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 mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
For more information:
Mike Sinclair, Halsin Partners
UK: +44(0)20 7318 2955 / C: +44(0)79 6802 2075
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.
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.