Great success from Exact Sciences!
Exact Sciences success is astounding.
On the same day (August 11) the FDA approved their new non-invasive colon cancer test (Cologuard) and simultaneously, CMS approved it for Medicare. Same day, two federal agencies made major complementary regulatory decisions. Normally, CMS takes 2-3 years to decide that they pay for a drug, device, test that has been approved by FDA.
Cologuard was the first test put through the parallel review process and it was a success. The review was not only parallel–it was simultaneous!
Good work Exact Science. Good work US government.