FDA OKs Next-Gen Cologuard Test for CRC Screening

The US Food and Drug Administration (FDA) approved Exact Sciences’ next-generation multitarget stool DNA (mt-sDNA) test, Cologuard Plus, for use in adults 45 or older who are at average risk for colorectal cancer (CRC).

Developed in collaboration with Mayo Clinic, the company notes in the news release announcing its approval that this noninvasive test “raises the performance bar.” 

The company says the enhanced sensitivity will help minimize unnecessary follow-up colonoscopy procedures by reducing the odds of a false-positive screening test. 

Enhanced sample stability components also will give patients more time to return their sample to the lab.

Cologuard Plus tests for three novel methylated DNA markers and fecal hemoglobin.

The BLUE-C Study 

The FDA’s approval was based on the results of the BLUE-C study involving more than 20,000 adults at average risk for CRC that compared the next-generation mt-sDNA test with a fecal immunochemical test (FIT) and colonoscopy. 

According to the BLUE-C results, the sensitivities of Cologuard Plus were 95% for CRC and 43% for advanced precancerous lesions, at 94% specificity with no findings on colonoscopy. 

The BLUE-C results also showed that the test significantly outperformed FIT for sensitivity for CRC overall, CRC stages I-III, high-grade dysplasia, and advanced precancerous lesions.

“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early — when it is most treatable — and find advanced precancers, which can prevent cases of this cancer,” Thomas F. Imperiale, MD, professor of medicine at the Indiana University School of Medicine and research scientist at the Regenstrief Institute, said in the news release. 

“The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients,” said Imperiale, who served as principal investigator of the BLUE-C study. 

The company plans to launch Cologuard Plus in 2025. 

They anticipate that it will be covered by Medicare and included in the United States Preventive Services Task Force (USPSTF) guidelines and within quality measures.