The trial highlighted a 100% sensitivity rate for CRC in the age group of 45-49 years. Credit: Kateryna Kon/Shutterstock.com.

The US Food and Drug Administration (FDA) has granted approval to Geneoscopy’s ColoSense, a noninvasive multi-target stool RNA (mt-sRNA) test for colorectal cancer (CRC) screening in adults aged 45 and older.

The ColoSense test is designed to detect colorectal neoplasia-associated RNA markers and occult haemoglobin in human stool.

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The test, which is to be used with the ColoSense Collection Kit, Test Kit and Software, as well as specific instruments, is performed at a single site at Geneoscopy.

ColoSense has been designated as a breakthrough device by the FDA and is said to be the first to utilise RNA biomarkers for a dynamic view of disease activity.

The CRC-PREVENT trial, which included participants from diverse backgrounds, showed that ColoSense had a 93% sensitivity for CRC detection and a 45% sensitivity for advanced adenomas (AA) detection in average-risk individuals.

Furthermore, the trial highlighted a 100% sensitivity rate for CRC in the age group of 45-49 years, which is significant for early-age onset CRC prevention.

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Geneoscopy CEO and co-founder Andrew Barnell said: “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.

“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 is preparing for a commercial launch of ColoSense in collaboration with Labcorp, aiming for availability later this year or early 2025.

Last year, the company signed a multi-year agreement with Labcorp for the distribution of the mt-sRNA colorectal cancer screening test.