Industry Buzz: Cologuard’s Wild September Ride

The month of September was a rollercoaster for a product that has in many ways become the face of the consumer genetic testing market, Exact Sciences’ Cologuard.

The Growth of Cologuard

The first stool multi-target stool DNA test (mtSDNA) for colorectal cancer screening, Cologuard has enjoyed great commercial success since its 2014 launch. The test is covered by Medicare and most private insurers. Nearly 174,000 doctors have ordered the test, including 142,000 primary care physicians. Each week, 900 new doctors join the list of orderers each week. According to Exact Sciences’ most recent earnings report, Cologuard rakes in average revenues of $479 per test at an average cost of $123. It now accounts for 6% of the total U.S. colorectal cancer testing market.

The Downs: New CMS Report Casts Doubt on Cologuard

But on Sept. 4, the giddiness was tempered with the release of a new CMS-sponsored research report finding Cologuard “less effective and considerably more costly” than alternatives. “At its current reimbursement rate, triennial mtSDNA testing . . . is an inefficient screening option,” according to the paper published in the Sept. 4, 2019, issue of PLOS ONE.

Exact blasted the report for understating Cologuard’s value proposition by employing unrealistic assumptions, such as adherence rates (i.e., 100% adherence, or relative adherence over a fairly narrow range) for screening, follow-up and surveillance procedures.” But news of the report sent Exact Sciences shares sharply downward. Worse, the report came on the eve of a crucial decision from the U.S. Preventive Services Task Force (USPSTF) on whether to recommend mtSDNA colorectal cancer screening.

The Ups: FDA Expands Cologuard Label Clearance

But on Sept. 23, less than three weeks after the CMS-sponsored report, the mood turned completely around again when Exact Sciences announced that the FDA had widened its approval for Cologuard to include people age 45 and older, as opposed to the previous approval for people age 50 and older. The clearance, which came a year before the company expected, adds 19 million potential users to Cologuard’s target market. It also greatly improves the prospects for thumbs-up from the USPSTF decision on mtSDNA colorectal cancer screening.