Key Insights:
- Geneoscopy, Inc. has received FDA approval for ColoSense™, a noninvasive multi-target stool RNA (mt-sRNA) test for colorectal cancer (CRC) screening. This test is designed for adults aged 45 or older who are at average risk for developing CRC.
- ColoSense™ has been designated as a Breakthrough Device by the FDA, recognizing its potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases.
- In the CRC-PREVENT trial, ColoSense™ demonstrated a high sensitivity of 93% for detecting CRC and identified 100% of stage I colorectal cancers, the most curable stage. It also detected 45% of advanced adenomas, highlighting its potential to identify precancerous conditions.
Conclusion: The FDA approval of ColoSense™ marks a significant advancement in colorectal cancer screening technology, offering a noninvasive, highly sensitive option that could improve early detection and management of the disease. This could potentially lead to better patient outcomes and reduce the incidence and mortality associated with colorectal cancer. Geneoscopy’s collaboration with Labcorp to launch ColoSense™ reflects a strategic approach to enhancing accessibility and effectiveness in CRC screening.