If the USPSTF recommendations are finalized, most insurers would need to reimburse Exact Sciences’ US FDA-approved at-home stool DNA test for colorectal cancer and encourage doctors to prescribe more at-home testing.

While only two devices have received approval and a national coverage determination through US FDA/CMS' parallel review program, a top CMS official says industry needs to look beyond just the numbers. Instead, she says the parallel review program is part of a sea-change that has allowed for better communication between CMS, FDA and sponsors.

Sponsors participating in the US FDA’s Accreditation Scheme for Conformity Assessment pilot program should work closely with the lab and be prepared for a few extra steps in putting a submission together, agency staff say.