title: Exact Sciences' experience with the FDA and CMS parallel review program.
abstract: Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer death among men and women combined in the USA. Although the benefits of early CRC detection are widely recognized, screening rates are suboptimal. Cologuard is a multitarget stool DNA screening test that offers a unique non-invasive option for CRC screening. Cologuard was the first product to be reviewed under a pilot parallel review program jointly conducted by the US FDA and the Centers for Medicare & Medicaid Services (CMS). This parallel review process shortened the overall review for Cologuard and resulted in a preliminary National Coverage Determination that coincided with FDA approval.
authors.affiliation: a Exact Sciences Corporation, 441 Charmany Drive, Madison, WI 53719, USA.
authors.forename: John R
authors.initials: JR
authors.lastname: Ridge
authors.forename: Sandra
authors.initials: S
authors.lastname: Statz
mesh_terms: D014487:Centers for Medicare and Medicaid Services, U.S.; D015179:Colorectal Neoplasms / Q000175:diagnosis; D004273:DNA, Neoplasm; D057069:Diagnostic Test Approval; D055088:Early Detection of Cancer / Q000379:methods; D005243:Feces / Q000737:chemistry; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D014600:Utilization Review
chemical_list: D004273:DNA, Neoplasm
keywords: Cologuard®; FDA-CMS parallel review; colorectal cancer screening; in vitro diagnostic; multitarget stool DNA; premarket authorization; reimbursement; stool DNA testing; stool DNA-based colorectal cancer screening test