FDA approves ColoSense, mt-sRNA screening test from Geneoscopy

Geneoscopy has announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, ColoSense. ColoSense is a screening test for adults, 45 years of age or older, who are at average risk for developing colorectal cancer (CRC).

ColoSense is the first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. Research shows that RNA biomarkers are not subject to age-related factors that can lead to variability in test performance across different age groups.

“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.”

Geneoscopy’s CRC-PREVENT trial showed ColoSense demonstrating 93% sensitivity for CRC and identified 100% of CRC in Stage I, when the disease is most curable. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.

"The FDA approval of ColoSense is a step forward in the mission to end colorectal cancer,” said Michael Sapienza, CEO of the Colorectal Cancer Alliance. “This innovative, noninvasive test will enhance our arsenal of tools to detect CRC early and effectively, particularly in younger adults who are not getting checked as recommended. We congratulate Geneoscopy and recognize this development as an innovation that will reduce the terrible burden of this disease.”  

Colorectal cancer is the second deadliest cancer in the United States. However, millions of eligible Americans do not get screened due to a lack of access to or avoidance of invasive options like colonoscopies. CRC incidence rates are also rising among people under 50 years old, prompting a recent shift in the United States Preventive Services Task Force’s guidelines to recommend initiation of CRC screening at age 45. 

Underscoring the critical nature of this issue, the American Cancer Society recently reported that colorectal cancer is now the leading cause of cancer death for males and the second leading cause of death for females under 50. Further compounding this challenge, approximately 40% of unscreened and eligible Americans are ages 45-49.

FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening. 

Geneoscopy will launch ColoSense in collaboration with Labcorp.

Content adapted from a Geneoscopy press release.