MADISON, WI. – Exact Sciences Corp. (NASDAQ: EXAS) today announced that the U.S. Food and Drug Administration's (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory 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.
Non-invasive, Stool-based DNA Test Shown to Detect 92% of People with Colorectal Cancer compared to 74% for the Fecal Immunochemical Test (FIT)
MADISON, WI. – Exact Sciences Corp. (Nasdaq: EXAS) today announced that results from its DeeP-C pivotal clinical study have been published online in the New England Journal of Medicine. The peer-reviewed study, “Multi-target Stool DNA Testing for Colorectal-Cancer Screening” will also appear in the journal’s April 3, 2014 print issue.
Researchers at the University of Michigan this week found that recommendation guidelines for colon cancer screenings may be contributing to both overuse of screening in patients in poor health and underuse of screening in patients in good health.
Physicians begin recommending colon cancer screening for average risk patients starting at age 50, and most insurers use quality measures that encourage 50- to 75-year olds to get screened. However, the results of a recent study indicate that it may be beneficial to include benefit to the patient as part of these quality measures instead of age alone.