US panel cuts age for colorectal cancer screening, expands payor’s mandate


Dive brief:

  • The US Task Force on Preventive Services finalized its position on colorectal cancer screening, confirming that adults 45 years and older should be tested.

  • The main recommendations of the USPSTF are unchanged from the draft opinion released in October, although it changed some aspects. Notably, the USPSTF now recommends screening with Cologuard from Exact Sciences every one to three years, rather than every three years.

  • William Blair analysts called the recommendations positive for Exact Sciences, which “will help drive adoption in this important new age group.” Exact Sciences framed counseling as a chance to stimulate growth by targeting 19 million people in the screening cohort.

Dive overview:

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

Exact Sciences is positioned to benefit from the change. The USPSTF has been recommending Exact Sciences’ Cologuard test since 2016. The US task force recommends two other stool-based tests, namely gFOBT and high-sensitivity FIT, as well as direct visualization approaches such as colonoscopy. . Exact Sciences is betting that the sensitivity and non-invasive nature of its test will enable it to gain market share and should step up its efforts to reach younger people.

“We expect Exact to become even more aggressive in targeting this nascent patient population with digital and other marketing to highlight new guidelines and the nature of home testing of the product, which could be a more driving force. significant adoption among these younger, more active population, ”analysts William Blair wrote in a note to investors.

The USPSTF revised the details of its recommendations for Cologuard and other stool-based tests in the final document, while leaving its key findings unchanged. The final version opens the door to the use of Cologuard each year, giving Sciences Exact the opportunity to benefit from more frequent screening.

The draft indicated that screening with Cologuard each year “would result in more colonoscopies than annual screening with FIT.” The USPSTF softened its position in the final text, explaining that this 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 by estimated follow-up colonoscopy versus no screening. “

Investors welcomed the finalization of the recommendations, sending actions in Exact Sciences up 2%. William Blair analysts expect changes to insurance coverage “to unfold over the next 12-18 months, as was the case with the initial inclusion of Cologuard in the guidelines ago. five years “.

At one point, Cologuard appears poised to face competition from liquid biopsies under development at Freenome, Guardant Health and Exact Sciences itself. The USPSTF has yet to say whether it will conduct an ad hoc review of the technology or wait for the next update on its key screening recommendations.


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