Sam Brusco, Associate Editor05.07.24
Geneoscopy, a company that develops diagnostic tests for gastrointestinal health, has earned U.S. Food and Drug Administration (FDA) approval for its ColoSense noninvasive colorectal cancer (CRC) screening test.
The test is for adults aged 45 and older who are at typical risk for developing CRC. The FDA designated ColoSense as a Breakthrough Device—it’s the first noninvasive CRC screening test that offers a dynamic view of disease activity by using RNA biomarkers.
The company’s CRC-PREVENT trial assessed patients 45 and older from diverse racial, ethnic, and socioeconomic backgrounds. It used a novel, decentralized enrollment, with 64% of patients never having been screened for colorectal cancer and 68% who hadn’t scheduled a colonoscopy at the time of enrollment.
ColoSense, according to the company, showed 93% sensitivity for CRC. The screening test also identified 100% of CRC in Stage I, when the disease is most curable.
It also spotted 45% of advanced adenomas (AA), when the disease it at its most preventable. The study also reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49.
Geneoscopy said it plans to launch ColoSense later this year or by early 2025. The company will launch it in partnership with Labcorp.
“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.”
The test is for adults aged 45 and older who are at typical risk for developing CRC. The FDA designated ColoSense as a Breakthrough Device—it’s the first noninvasive CRC screening test that offers a dynamic view of disease activity by using RNA biomarkers.
The company’s CRC-PREVENT trial assessed patients 45 and older from diverse racial, ethnic, and socioeconomic backgrounds. It used a novel, decentralized enrollment, with 64% of patients never having been screened for colorectal cancer and 68% who hadn’t scheduled a colonoscopy at the time of enrollment.
ColoSense, according to the company, showed 93% sensitivity for CRC. The screening test also identified 100% of CRC in Stage I, when the disease is most curable.
It also spotted 45% of advanced adenomas (AA), when the disease it at its most preventable. The study also reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49.
Geneoscopy said it plans to launch ColoSense later this year or by early 2025. The company will launch it in partnership with Labcorp.
“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.”