FDA Approves New Stool RNA Screening Test for Colon Cancer

In a clinical trial, ColoSense, developed by Geneoscopy, Inc., performed better than the standard fecal immunochemical test (FIT) and showed similar or improved sensitivity to the Cologuard test in detecting colorectal cancer.

On May 6, Geneoscopy, Inc., a life sciences company, announced the U.S. Food and Drug Administration's (FDA) approval of ColoSense, its multi-target stool RNA (mt-sRNA) colorectal cancer screening test. The new screening tool is the first to use RNA biomarkers to detect the presence of colon cancer and advanced adenomas.

The new RNA-based test is a non-invasive alternative to colonoscopy for adults ages 45 and older with an average risk of colon cancer. Completing the test involves collecting a stool sample at home and sending it to a lab for analysis.

The FDA approved ColoSense based on CRC-PREVENT trial results, which involved participants aged 45 or older, including individuals who had never been screened for colon cancer.

The results showed that ColoSense has a 93% sensitivity for colorectal cancer and 45% sensitivity for advanced adenomas. In average-risk participants ages 45 to 49, the new test showed 100% sensitivity in detecting colon cancer and 44% sensitivity for advanced adenomas.

Geneoscopy says its test offers a promising new tool to combat early-onset colon cancer, which is increasing at an alarming rate among younger people. Since the U.S. Preventive Services Task Force (USPSTF) recommends that adults aged 45 to 75 should be screened for colorectal cancer, the new test may provide an option for people who would otherwise avoid screening.

"Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting colorectal cancer and advanced adenomas," said Andrew Barnell, CEO and co-founder of Geneoscopy, in a press release.

How does ColoSense compare to other colon cancer tests?

The CRC-PREVENT trial results found that compared to ColoSense, the fecal immunochemical test (FIT) had a 78% sensitivity for colon cancer and a 29% sensitivity for detecting advanced adenomas.

Cologuard, an FDA-approved mt-sDNA stool test developed by Exact Sciences, has a 92% sensitivity for detecting colorectal cancer and a 42% sensitivity for detecting advanced adenomas. A next-generation Cologaurd test, which has shown improved sensitivity over Cologuard in a clinical trial, may be available in 2025 if FDA-approved.

Colonoscopy is considered the "gold standard" of colorectal cancer screening. It has a 75% to 95% sensitivity for cancer with an 86% specificity. Moreover, a surgeon can remove any suspected growths or polyps during the procedure.

However, according to the USPSTF, perforation of the bowel occurs in about four out of 10,000, and significant bleeding occurs in around eight out of 10,000 colonoscopy procedures.

For people who want to screen for colon cancer, ColoSense and other stool tests like Cologuard offer a less invasive option to colonoscopy. However, if the test comes back positive, a person will need to have a follow-up colonoscopy to determine if cancer is present.

Moreover, Geneoscopy says that its new test is not a replacement for colonoscopy in people at high risk for colorectal cancer.

With FDA approval in hand, the company plans to launch ColoSense later this year or in 2025 in collaboration with Labcorp, a firm that provides laboratory services.

Since the Affordable Care Act requires insurers to cover colorectal screening tests, the new test will likely be available to Americans for little or no out-of-pocket cost.

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