FDA Approves Cologuard Plus Stool DNA Test for Colorectal Cancer Screening

Microscopic image of colon cancer cell - Generated with Google Gemini AI

The FDA has approved the Cologuard Plus test, a noninvasive stool DNA test to screen adults 45 and older at average risk for colorectal cancer (CRC).¹

“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,” said Thomas F. Imperiale, MD, professor of medicine at Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for the BLUE-C study (NCT04144738), in a press 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.”

Findings from the BLUE-C study supported the approval. Cologuard Plus demonstrated 95% cancer sensitivity and 43% sensitivity for advanced precancerous lesions, with 94% specific with no findings on colonoscopy. Cologuard Plus outperformed an independent fecal immunochemical test on overall CRC, stage I to III CRC, high-grade dysplasia, and advanced precancerous lesion sensitivity.

More than 20,000 patients aged 40 and older were included in the prospective study, and about 40% identified as Hispanic or Latino, Black, Asian, American Indian or Alaska Native, or Pacific Islander.

In May 2024, the FDA approved ColoSense, another noninvasive stool test for the early detection of colorectal cancer in patients aged 45 and older.² ColoSense™ demonstrated a 93% sensitivity for detecting CRC. The test also identified 100% of stage I CRC and detected 45% of advanced adenomas. Notably, the CRC and advanced adenoma sensitivities were 100% and 44%, respectively, in patients between 45 and 49 years of age.

REFERENCES:

1. FDA approves Exact Sciences’ Cologuard Plus test, setting a new benchmark in non-invasive colorectal cancer screening. News release. Exact Sciences. October 4, 2024. Accessed October 4, 2024. https://tinyurl.com/tzh2b9fp

2. FDA approves ColoSense™ - Geneoscopy's noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test. News release. Geneoscopy. May 6, 2024. Accessed October 4, 2024. https://tinyurl.com/5n8hwx4t