FDA Approves the First Multitarget Stool RNA Test for Colon and Rectal Cancer Screening
ColoSense (Geneoscopy, Inc), a multitarget stool RNA (mt-sRNA) test for colorectal cancer screening in average-risk adults aged 45 and older, received United States Food and Drug Administration (FDA) approval on May 6, 2024.
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- In average-risk individuals, ColoSense showed 93% sensitivity for detecting colorectal cancer (CRC) and 45% sensitivity for detecting advanced adenomas.
- RC-PREVENT evaluated more than 1,800 average-risk individuals aged 45-49, representing more than 20% of all participants. Results in this subgroup showed 100% sensitivity for detecting CRC and 44% sensitivity for advanced adenomas.
- This 100% sensitivity offers a promising new tool, particularly for addressing early-onset CRC.
Designated a breakthrough device by the FDA, ColoSense detects occult hemoglobin in human stool and colorectal neoplasia-associated RNA markers .
Colorectal cancer is the 3rd most common cancer worldwide in both women and men, and early diagnosis is known to substantially improve treatment success. Increasing cases before age 50 further highlight the importance of early screening and diagnosis. We therefore recommend regular screening for everyone starting at age 45 (people at risk of hereditary cancer should begin earlier). One of the most effective screening methods, colonoscopy, is considered the diagnostic gold standard. However, its preparation and invasive nature make many people hesitant. This has increased the need for alternative screening methods . New-generation technologies such as multitarget stool RNA (mt-sRNA) testing address this need. As a noninvasive approach detecting stool RNA markers and occult hemoglobin, mt-sRNA offers a promising alternative for people avoiding colonoscopy. It may represent a milestone in colorectal cancer screening, facilitating early diagnosis by increasing screening uptake.
A positive ColoSense result may indicate CRC, advanced adenomas, or other precancerous lesions and should be followed by colonoscopy, according to a company press release.
A test's "sensitivity" is its ability to correctly identify people who have a particular disease or condition. More technically, it is the proportion of people with the disease whose test is positive. It indicates how many people who actually have the disease are correctly identified as positive.
The CRC-PREVENT Study
FDA approval was based on CRC-PREVENT, which evaluated the ColoSense mt-sRNA test in diverse adult groups undergoing colonoscopy.
Mt-sRNA results were compared with colonoscopy results.
- Across all average-risk individuals, mt-sRNA sensitivity was 93% for CRC, 100% for early-stage (stage I) CRC, and 45% for advanced adenomas.
- In a subgroup aged 45-49, sensitivity was 100% for CRC and 44% for advanced adenomas.
Trial results were presented at last year's American College of Gastroenterology annual meeting and published in JAMA.
CRC is the second leading cause of cancer death in the United States, and adherence to recommended colonoscopy screening remains low, at approximately 60%.
Increasing CRC cases in people under 50 have prompted the need to begin screening at age 45.
Geneoscopy plans to launch ColoSense in the United States later this year or in early 2025.
Sources
2. Barnell EK, Wurtzler EM, La Rocca J, et al. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023;330(18):1760–1768. doi:10.1001/jama.2023.22231
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