FDA approved the first noninvasive DNA colorectal cancer screening kit cologuard

Source: Biovalley 2014-08-14 exact science company announced on August 12 that FDA has approved the non-invasive, stool DNA colorectal cancer screening kit cologuard On the same day, exact also received a medical insurance coverage memorandum from the center for Medicare and Medicaid Services (CMS) proposing to provide cologuard with nationwide medical coverage Cologuard is the first FDA approved non-invasive colorectal cancer screening kit, which can detect 92% of cancers and 69% of advanced precancerous polyps in the average risk population by analyzing fecal DNA and blood biomarkers Cologuard can be obtained through health care institutions to provide an easy-to-use screening kit for people aged 50 and over with an average risk of colorectal cancer, enabling them to carry out at home and helping to protect their privacy Cologuard is the first product to enter the pilot project of joint parallel review of FDA and CMS In this project, two institutions review medical devices at the same time, which helps to shorten the time between FDA approval and medical insurance coverage At the end of the public consultation period, the final national coverage is expected to be released in October / November this year Cologuard was designed to detect biomarkers from DNA from cancer cells that had come off the colon during digestion and from stool blood After the doctor orders cologuard, the kit is directly mailed to the patient's home, and then the patient uses the stool collection box in the cologuard kit to collect feces, and then the kit is sent back to the exact Laboratory for testing by prepaid mail Cologuard sells for $599 at a health care provider, and patients can receive test results within two weeks of returning Colorectal cancer is a highly preventable cancer that can be detected in the early stages of the disease through recommended screening guidelines About 60% of colorectal cancer cases have reached advanced stage at the time of detection, which makes the treatment more difficult Therefore, there is an urgent need for new, patient-friendly screening options to prevent colorectal cancer or to detect cancer at an early stage that can be treated Since more than half of colorectal cancer-related deaths can be avoided by routine screening, cologuard, as another screening option, can significantly improve the compliance of screening, thus improving the screening rate and saving more lives.