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The US Food and Drug Administration (FDA) has granted approval to ColoSense, a multitarget stool RNA (mt-sRNA) test developed by Geneoscopy, Inc, for colorectal cancer (CRC) screening in adults aged 45 or older who are at average risk for CRC. This approval marks a significant milestone in the fight against CRC, the second deadliest cancer in the United States.
ColoSense, which received breakthrough device designation by the FDA, operates by detecting colorectal neoplasia–associated RNA markers along with the presence of occult hemoglobin in human stool. According to a recent news release by the company, a positive ColoSense test result may indicate the presence of CRC, advanced adenomas, or serrated precancerous lesions, warranting further investigation through colonoscopy.
The FDA’s decision was informed by the results of the CRC-PREVENT trial, which assessed the efficacy of the ColoSense mt-sRNA test in a diverse cohort of adults undergoing colonoscopy. Notably, the trial demonstrated promising sensitivity rates, with the mt-sRNA test exhibiting 93% sensitivity for CRC among all average-risk individuals, and 100% sensitivity for early-stage CRC (stage I). Moreover, in the subgroup aged 45-49 years, sensitivity for CRC was 100%, underlining the potential impact of the test in younger populations.
Presented at the American College of Gastroenterology annual meeting and concurrently published in JAMA, the trial results shed light on the importance of expanding CRC screening modalities, particularly given the persistently low adherence rates to recommended colonoscopies, which hover around 60%. As cases of CRC continue to rise among individuals younger than 50 years, the United States Preventive Services Task Force recently recommended initiating CRC screening at age 45 years.
Anjee Davis, president of Fight CRC, emphasized the significance of innovative screening approaches in tackling the growing burden of CRC. Davis stated in the news release, “The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening. It’s essential to eliminate obstacles and broaden the availability of screening methods for healthcare providers and patients.” Davis expressed hope that the introduction of FDA-approved diagnostic tools like ColoSense will bolster access and ultimately reduce the impact of late-stage colorectal cancer diagnoses.
Looking ahead, Geneoscopy, Inc aims to make ColoSense available in the United States later this year or early in 2025, offering a promising tool in the early detection and prevention of colorectal cancer among individuals at average risk.
