Stool DNA colorectal cancer screening assay regulatory update

CMS proposed reimbursement of $502 for Cologuard a day after issuing a final National Coverage Determination (NCD) for the non-invasive stool DNA screening test for colorectal cancer. The final NCD confirms the initial CMS draft, establishing national coverage for the test once every 3 years for asymptomatic beneficiaries aged 50-85 who are at average risk of developing colorectal cancer (see BioCentury, Aug. 18). Exact said the agency's proposed payment matches the amount the company had requested. The final reimbursement schedule will be made after a 30-day public comment period.

In August, FDA approved a PMA for Cologuard and Exact Sciences launched it at a cost of $599 in the U.S. The product is the first to obtain approval through a pilot parallel FDA/CMS assessment. Cologuard utilizes a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene. ...