FDA Approves Novel Noninvasive Multitarget Stool RNA CRC Screening Test: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

Last week, we reported on the US Food and Drug Administration (FDA) approval of ColoSense, a noninvasive multitarget stool RNA (mt-sRNA) colorectal cancer (CRC) screening test for use in adults aged 45 years or older considered at average risk for developing CRC.

The approval

ColoSense is the first noninvasive CRC screening test to give a dynamic view of disease activity via RNA biomarkers.

The approval is based on data from the pivotal CRC-PREVENT trial, a phase 3, blinded, prospective, cross-sectional study of 8920 individuals identified using social media platforms and enrolled between June 2021 and June 2022. Participants were aged 45 years and older and represented diverse racial, ethnic, and socioeconomic backgrounds. Unlike traditional centralized clinical trials where participants are usually already engaged in a health care screening program, ColoSense investigators used a novel decentralized enrollment strategy that resulted in a cohort in which 64% had never been screened for CRC and more than two-thirds (68%) of whom did not have a colonoscopy screening scheduled at the time of study enrollment.

The study found that ColoSense sensitivity for detecting CRC was 94% and for detecting advanced adenomas, when the disease is most preventable, was 46%. The test’s specificity for no lesions on colonoscopy was 88%. Importantly the test maintained high performance in adults aged 45 to 49 years (sensitivity for CRC, 100% and for advanced adenoma 45%), a population for whom screening is now recommended.

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