Warning letter blocks DNA stool test coverage
This article was originally published in The Gray Sheet
Executive Summary
CMS says Jan. 30 it will not cover Exact Science's PreGen-Plus assay as a screening alternative to colonoscopy because the test is no longer on the market. CMS decided to open a national coverage decision on the DNA stool test in August at Exact Science's request, but in October the firm received a 1warning letter from FDA stating that PreGen-Plus does not qualify as a lab-developed test and needs to undergo regulatory review (2"The Gray Sheet" Aug. 6, 2007, p. 9). In December, Exact Science asked CMS if it could withdraw its coverage request. "After a commercially available stool DNA test is cleared or approved by the FDA, a request for reconsideration would be anticipated," CMS says. The agency has until May to finalize its decision