Dive Brief:

• The U.S. Preventive Services Task Force has recommended screening people for colorectal cancer once they turn 45 years old.

• USPSTF recommended lowering the starting age from 50 after modeling found the change would avert one additional colorectal cancer death per 1,000 adults. The task force is particularly keen that Black adults are screened from 45, reflecting the disproportionate risk colorectal cancer poses to them. 

• Exact Sciences, which sells the USPSTF-recommended Cologuard screening test, welcomed the change, which it sees furthering its efforts to reach 20 million Americans. 

Dive Insight:

In 2016, USPSTF added stool-based kit Cologuard to its recommended screening tests and set the age range at 50 to 75 years. The latest update states there is "high certainty that the net benefit is substantial" in the 50-to-75 age range but also provides slightly more equivocal support for starting screening at age 45.

As a grade B recommendation, USPSTF is advising physicians to start screening at age 45 on the grounds that "there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial." In practical terms, the lower level of certainty may have little impact. The panel recommends physicians offer all services that it classes as grade A or B recommendations.  

The group reached that position after reviewing data on the number of colorectal cancer patients aged 45 to 49 years old. The research identified an "epidemiologic trend of increasing incidence in adults younger than age 50 years, which is thought to reflect cohort effects, with younger birth cohorts at greater risk for colorectal cancer than older cohorts."

Factoring that trend into modeling of the benefits of screening at a younger age pointed to the value of starting at 45. The task force calculates the U.S. can avert two to three cases of colorectal cancer per 1,000 adults by lowering the screening age. The aversion of those cases is predicted to translate into the saving of one life and up to 27 life-years per 1,000 adults. Framed another way, screening at 45 years grants an extra eight to 10 days of life per person screened. 

The proposal comes 13 months after FDA expanded the Cologuard label to support use in adults aged 45 years and up. Talking to investors in July, Exact Sciences CFO Jeff Elliott said there are 20 million people in the 45-to-49 age group. As Elliott sees it, the stool-based Cologuard is a better fit for the lifestyles of people in the demographic, who are pre-retirement, than colonoscopies. 

Exact Sciences has started to see Cologuard sales growth in the demographic and, with it calculating that incidence and mortality in the age group have risen 50% over the past 20 years, sees a strong case for further expansion. Elliott pointed to new third-party recommendations as the next trigger for growth.

“I think the next big leg of growth we expect is through greater reimbursement that likely hinges on guideline inclusion,” Elliott said.

USPSTF is accepting feedback on the recommendations until Nov. 23.