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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.