US panel trims colorectal cancer screening age, opens door to annual Cologuard use

Dive Brief:

The U.S. Preventive Services Task Force has finalized its position on screening for colorectal cancer, confirming that adults aged 45 years and up should be tested.
USPSTF's main recommendations are unchanged from the draft advice released in October, although it has tweaked aspects. Notably, USPSTF now recommends screening with Exact Sciences' Cologuard every one to three years, rather than every three years.
Analysts at William Blair called the recommendations a positive for Exact Sciences that "will help drive uptake in this important new age category." Exact Sciences has framed the guidance as a chance to drive growth by targeting 19 million people in the screening cohort.

Dive Insight:

The headline takeaway from the final USPSTF recommendations is that the body now recommends the screening of adults aged 45 to 49 years old for colorectal cancer. USPSTF previously supported screening people aged 50 to 75 years. The younger cohort is covered by a grade B recommendation compared to the grade A recommendation in the over 50s, but that still means private insurers have to cover the screening of adults aged 45 to 49 years under the Affordable Care Act.

Exact Sciences is positioned to benefit from the change. USPSTF has recommended Exact Sciences' stool-based test Cologuard since 2016. The U.S. task force recommends two other stool-based tests, namely high-sensitivity gFOBT and FIT, as well as direct visualization approaches such as colonoscopy. Exact Sciences is betting the sensitivity and non-invasive nature of its test will help it win share and is tipped to step up its efforts to reach younger people.

"We would expect Exact to become even more aggressive in targeting this nascent patient population with digital and other marketing to highlight the new guidelines and the at-home testing nature of the product, which could be a more important driver of uptake in this younger, more active population," the William Blair analysts wrote in a note to investors.

USPSTF revised details of its recommendations on Cologuard and other stool-based tests in the final document, while leaving its core conclusions unchanged. The final version opens the door to the use of Cologuard every year, giving Exact Sciences a chance to benefit from more frequent screening.

The draft version said screening with Cologuard every year "would result in more colonoscopies than annual screening with FIT." USPSTF has softened its position in the final text, explaining that view is based on "modeling estimates" and adding the statement that "[Cologuard] every 1 to 3 years is estimated to provide a reasonable balance of life years gained per estimated follow-up colonoscopy compared with no screening."

Investors welcomed the finalization of the recommendations, sending shares in Exact Sciences up 2%. Analysts at William Blair expect the changes to insurance coverage "to play out over the next 12 to 18 months as was the case with Cologuard's initial inclusion into guidelines five years ago."

At some point, Cologuard looks set to face competition from liquid biopsies in development at Freenome, Guardant Health and Exact Sciences itself. USPSTF is yet to say whether it will conduct an ad-hoc review of the technology or wait until it next updates its main screening recommendations.