Boston, MA 08/13/2014 (wallstreetpr) – EXACT Sciences Corporation (NASDAQ:EXAS) on August 12, 2014 announced that the U.S. Food and Drug Administration (FDA) gave its approval to Cologuard. This is the non-invasive, stool DNA cancer screening test of the company and also the first such screening test for colorectal cancer, capable of analyzing not just stool DNA, but also blood biomarkers.
About Cologuard
It has been found that Cologuard can diagnose around 92% of cancers as well as 69% of most advanced precancerous polyps among even the average risk patients. This test is also available through healthcare providers with ease and allows people of the age 50 years and above, the access to easily accessible and used screening test which can be done in the privacy of home only.
CMS Proposed Coverage Memorandum
After the screening test got approval from the FDA, EXACT Sciences Corporation (NASDAQ:EXAS) also proposed coverage memorandum from Centers for Medicare and Medicaid Services, abbreviated as CMS. It is worth noticing that Cologuard is the first of its kind product which participates in the parallel review pilot program of FDA and CMS jointly. Both these agencies will now, side by side make a review of the medical devices in order to assist in bringing down the time duration between Medicare coverage as well as FDA approval.
In this regard, the final National Coverage Determination shall be posted in October or November 2014.
Statement from the Co-Inventor of Drug
The gastroenterologist as well as the co-inventor of Cologuard test, David Ahlquist said that the strong research which was conducted in order to seek FDA approval, proved that this type of non-invasive test is very sensitive for detection of colorectal cancer at an early stage along with the diagnosis of advanced precancerous polyps, which may develop in the cancer. He added that the test has been designed for higher accuracy as well as easy use of the patients. It also offers wider accessibility.
