The FDA has approved ColoSense (Geneoscopy, Inc), a multitarget stool RNA (mt-sRNA) test designed for colorectal cancer (CRC) screening among adults aged 45 or older who are at average risk for CRC. ColoSense, which received breakthrough device designation by the FDA, functions by detecting colorectal neoplasia–associated RNA markers along with the presence of occult hemoglobin in human stool. A positive result from the ColoSense test may indicate the presence of colorectal cancer (CRC), advanced adenomas, or serrated precancerous lesions, triggering the necessity for a follow-up colonoscopy, according to a press release issued by the company.
The FDA’s approval of ColoSense was based on the outcomes derived from the CRC-PREVENT trial, a comprehensive investigation into the efficacy of the ColoSense multitarget stool RNA (mt-sRNA) test conducted among a diverse cohort of adults undergoing colonoscopy. Throughout the trial, the performance of the ColoSense mt-sRNA test was meticulously evaluated and compared with the outcomes of colonoscopies, the current gold standard for CRC detection and diagnosis.
The CRC-PREVENT trial served as a pivotal study, providing crucial insights into the accuracy and reliability of the ColoSense mt-sRNA test in identifying various colorectal abnormalities. By correlating the results of the mt-sRNA test with those obtained through colonoscopies, researchers were able to ascertain the test’s sensitivity and specificity in detecting CRC, advanced adenomas, and serrated precancerous lesions.
Enhancing Early Detection and Management of Colorectal Cancer
This rigorous comparative analysis not only underscored the diagnostic capabilities of the ColoSense test but also validated its clinical utility as a non-invasive screening tool for CRC and its precursor lesions. The trial’s findings, which formed the basis of the FDA’s decision to approve ColoSense, demonstrated the test’s ability to effectively identify CRC and precancerous lesions accurately. This validation of ColoSense’s performance in a real-world clinical setting further solidifies its position as a valuable adjunctive tool in the early detection and management of colorectal abnormalities.
As a result, ColoSense offers clinicians and patients alike a reliable and convenient option for CRC screening, potentially leading to earlier detection, prompt intervention, and improved patient outcomes. Across all average-risk individuals, the mt-sRNA test exhibited a sensitivity of 93% for detecting CRC, 100% for identifying early-stage CRC (stage I), and 45% for advanced adenomas. In a subgroup analysis of individuals aged 45-49 years, the sensitivity was 100% for CRC and 44% for advanced adenomas. These trial outcomes were presented at the American College of Gastroenterology annual meeting last year and concurrently published in JAMA.
New Hope for Early Colorectal Cancer Screening in the U.S.
Colorectal cancer stands as the second leading cause of cancer-related deaths in the United States, with adherence rates to recommended colonoscopies for screening remaining persistently low, hovering around 60%. Moreover, there has been a notable increase in CRC cases among individuals under 50 years, prompting the United States Preventive Services Task Force to advocate for initiating CRC screening at the age of 45 years.
Anjee Davis, president of Fight CRC, emphasized the pressing need for innovative screening approaches amidst the growing number of adults diagnosed with colorectal cancer. Davis expressed hope that the introduction of new FDA-approved diagnostic tools, such as ColoSense, will help broaden access and elevate screening rates, consequently mitigating the impact of late-stage colorectal cancer diagnoses. Geneoscopy, Inc. intends to launch ColoSense in the United States later this year or in early 2025, expanding the array of available CRC screening methods.
Resource: Geneoscopy, May 06, 2024
