The FDA has approved Geneoscopy’s colorectal cancer screening test, which is the first such test based on RNA to be approved by the U.S. regulatory agency.
In a Phase III trial published last year, the CRC-PREVENT trial, the noninvasive, multitarget stool RNA test called ColoSense was significantly more sensitive than the commonly used fecal immunochemical test (FIT), which is widely used to test for early signs of colorectal cancer.
ColoSense was able to detect colorectal cancer in stool samples with a sensitivity of 94% and advanced adenomas with a sensitivity of 46% compared with a sensitivity of 78% and 29%, respectively, for the FIT test.
The specificity, or ability to detect false positive test results, of the ColoSense test is slightly lower than the FIT test at 88% vs 96% but is still well above the 80% minimum level set by the FDA.
Colorectal cancer is the second most deadly cancer in the United States, but numbers could be lower if these cancers were detected at an earlier stage. Many people in America do not have access to screening, or avoid it due to a fear of invasive procedures such as colonoscopies so there is a definite need for more noninvasive screening options.
In 2014, the DNA-based Cologuard test developed by Exact Sciences became the first noninvasive screening test approved by the FDA for colorectal cancer analyzing both stool and blood biomarkers. It is able to detect 92% of colorectal cancers and 69% of more advanced adenomas.
The ColoSense test is the second noninvasive molecular test approved by the FDA since the approval of Cologuard. It uses a multi-target stool RNA biomarker panel, designed to detect precancerous lesions and cancer.
“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 CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy.
“This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”
Following the approval, Geneoscopy now plans a commercial launch of the ColoSense test in collaboration with Labcorp either later this year or early in 2025.
