Increasing Revenue: New Colorectal Cancer Screening Guidelines Are a Windfall for Exact Sciences, Cologuard

If you held stock in Exact Sciences on May 17, chances are you went to bed happy on May 18. It was on May 18 that a U.S. government taskforce officially announced a change in its guidelines for colorectal cancer testing by recommending that screening begin at age 45, rather than 50. In addition to saving thousands of lives by promoting earlier detection, the announcement lifted the stock price of Exact Sciences, maker of Cologuard, the top selling molecular colorectal cancer screening tests that the task force recommends. The prospect of more users at an earlier age is certainly exciting news, especially since those late 40-somethings with commercial insurance won’t have to lay out any of their own money for Cologuard.

The Diagnostic Challenge

The New Colorectal Screening Recommendations

The U.S. Preventive Services Task Force (USPSTF) reviews its screening recommendations every four years. The new recommendations, which were published in the Journal of the American Medical Association on May 18, are an update to its previous 2016 guidelines and a final version of draft recommendations published in October 2020.

Colorectal cancer is the third leading cause of cancer death among adults in the U.S., with more than 52,000 people projected to die from the disease in 2021, the task force notes. Most colorectal cancer cases are diagnosed in people ages 65 to 74. Only 10.5 percent of new cases occur in those below age 50. However, the case incident rate among this group has steadily increased—at a nearly 15 percent clip between 2000 and 2016.

Unfortunately, there’s been no commensurate increase in colorectal cancer screening over this period. Accordingly, the new guidelines recommend that asymptomatic adults at average risk start colorectal cancer screening at age 45, rather than waiting until age 50 as the 2016 guidelines recommended. The new recommendation is in line with the American Cancer Society, which also recommended starting routine colorectal cancer screening at age 45 in 2018.

Significantly for Exact Sciences and other test makers, the task force assigns members of the 45 to 49 age group a “B” grade, as opposed to the “A” grade given to the age 50 to 75 members of the cohort. Even so, a B grade is enough to ensure members who have commercial insurance won’t have to pay out-of-pocket costs to receive their screenings under Affordable Care Act rules. First-dollar health insurance coverage for adults starting at age 45 could impact up to 15 million adults, according to the patient advocacy organization Colorectal Cancer Alliance.

USPSTF Colorectal Cancer Screening Recommendations

Ages	Recommendations	Grade
50 to 75	Screening for all members	A
45 to 49	Screening for all members	B
76 to 85	Screening for selective cases determined by clinician based on patient’s health, screening history and preferences	C

 

Takeaway: Impact on the Lab Industry

Reducing the starting age for colorectal cancer screening to age 45 with a “B” classification will significantly boost sales of molecular screening tests. The real breakthrough came in 2016, when the USPSTF first added molecular colorectal cancer screening to its guidelines. In addition to multitargeted stool DNA (mtDNA) tests like Cologuard, the task force recommends two other stool-based tests, namely high-sensitivity Guaiac-based fecal occult blood tests (gFOBT) and Fecal immunochemical tests (FIT), as well as direct visualization approaches like colonoscopy.

Stool-Based Tests
Test Type	Recommended Frequency
High-sensitivity gFOBT	Every year
FIT	Every year
mtDNA	Every 1 to 3 years based on manufacturer’s recommendations
Direct Visualization Tests
Test Type	Recommended Frequency
Colonoscopy	Every 10 years
CT colonography	Every 5 years
Flexible sigmoidoscopy	Every 5 years
Flexible sigmoidoscopy with FIT	Every 10 years + FIT every year

 

Exact Sciences is the clear market leader in mtDNA at-home colorectal testing with the greatest visibility among the late 40-somethings who will now be able to get screened for free each year, especially if it means avoiding colonoscopy.

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This article originally appeared in G2 Intelligence, Laboratory Industry Report, July 2021.