FDA Clears Exact Sciences' Next-Generation Colorectal Cancer Diagnostic Test

On Friday, the FDA approved Exact Sciences Corp.’s EXAS Cologuard Plus test, the company’s next-generation multi-target stool DNA test.

The Cologuard Plus test is now approved for adults ages 45 and older who are at average risk for colorectal cancer (CRC).

FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening.

Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.

Results from BLUE-C also show the Cologuard Plus test significantly outperformed an independent fecal immunochemical test for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.

The Cologuard Plus test will build on the Cologuard test, which has been used more than 17 million times.

The Cologuard test is a first-line colorectal cancer screening test for adults age 45 or older at average risk for the disease.

Upon launch in 2025, the Cologuard Plus test will be supported by Exact Sciences’ commercial organization ExactNexus technology platform for orders from over 350 health systems.

The non-invasive test is anticipated to be covered by Medicare.

The Cologuard Plus test demonstrates 91% specificity, including non-advanced findings, 93% specificity, including no findings, and 94% specificity when age-weighted to the U.S. population with no findings on colonoscopy.

In July this year, the FDA approved Guardant Health Inc.’s GH Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease.

The company says it is the first blood test approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield like all other non-invasive methods recommended in screening guidelines.

Price Action: EXAS stock is up 1.94% at $67.70 at the last check on Friday.

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