The FDA has approved Geneoscopy Inc.’s ColoSense multitarget stool RNA test for adults aged 45 years or older at average-risk for developing colorectal cancer, according to a company press release.
Previously granted FDA breakthrough device designation in January 2020, ColoSense is the “first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers,” Geneoscopy noted in the release.
“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.” − Andrew Barnell, CEO and co-founder of Geneoscopy.
“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,” Andrew Barnell, CEO and co-founder of Geneoscopy, said in the release. “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.”
The agency based its decision on data from the CRC-PREVENT study, which assessed more than 1,800 average-risk patients aged 45 to 49 years from different racial, ethnic and socioeconomic backgrounds.
According to study results, among all average-risk patients, ColoSense demonstrated 93% sensitivity for CRC and 45% sensitivity for advanced adenomas; notably, 100% of identified CRC were stage I. In a subset of patients aged 45 to 49 years, ColoSense demonstrated an improved sensitivity of 100% for CRC and a consistent 44% sensitivity for advanced adenomas.
“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening,” Anjee Davis, president of Fight CRC, said in the release. “It’s essential to eliminate obstacles and broaden the availability of screening methods for health care providers and patients. We hope that introducing new FDA-approved diagnostic tools, including stool-based tests like ColoSense, will help to advance access and increase screening rates, ultimately reducing the impact of late-stage colorectal cancer diagnoses.”
Geneoscopy plans to launch ColoSense in collaboration with Labcorp either late in 2024 or early 2025, and noted that the company is currently working with payors, professional societies and advocacy partners “to ensure patients have timely access to ColoSense to support CRC screening.”
