FDA Approves ColoSense, Novel Noninvasive Multitarget Stool RNA CRC Screening Test

On May 6, the US FDA approved 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.¹

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The approval, announced by developer Geneoscopy, is based on data from the pivotal CRC-PREVENT trial and follows the agency’s designation of ColoSense as a Breakthrough Device in January 2020.² Geneoscopy targets a commercial launch for the at-home test in late 2024 or early 2025, according to the company announcement.¹

Geneoscopy describes ColoSense as the first "noninvasive CRC screening test to provide a dynamic view of disease activity by using RNA biomarkers.”¹ RNA biomarkers resist “age-related methylation patterns” that are often the cause of variability in CRC screening performance across age groups, the company explained.¹

The pivotal CRC-PREVENT trial was a phase 3, blinded, prospective, cross-sectional study of 8920 individuals identified using social media platforms and enrolled between June 2021 and June 2022.³ 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.³

The study cohort had a mean age of 55 years with 4% self-identifying as Asian, 11% as Black, and 7% as Hispanic. Researchers reported that 0.40% had colorectal cancer and 6.8% had advanced adenomas.³ mt-sRNA test results, positive or negative, were compared with index lesions observed on colonoscopy. The primary outcomes of interest for CRC-PREVENT were sensitivity of the mt-sRNA test for detecting colorectal cancer and advanced adenomas and the specificity for no lesions on colonoscopy.³

The study found that ColoSense sensitivity for detecting CRC was 94% and for detecting advanced adenomas, when the disease is most preventable, was 46%.³ The test’s specificity for no lesions on colonoscopy was 88%.³ 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.³ ColoSense also “achieved a similar level of specificity compared with other molecular diagnostic tests,” CRC-PREVENT researchers wrote.³

CRC is now the second deadliest cancer in the US and yet lack of access to or avoidance of invasive colonoscopy testing keeps millions from guideline-recommended screening.¹ According to the American Cancer Society, CRC is the leading cause of cancer mortality among men and the second leading cause among women under age 50 years. Augmenting an already steep challenge, approximately 40% of adults who are eligible and unscreened are between the ages of 45 and 49.⁴

“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,” Anjee Davis, president of Fight CRC, said in the press statement.¹ “We hope that introducing new FDA-approved diagnostic tools, including stool-based tests like ColoSense, will help to advance access and increase screening rates, ultimately reducing the impact of late-stage colorectal cancer diagnoses.”¹

References
1. FDA approves ColoSense Geneoscopy's noninvasive multitarget stoo RNA (mg-sRNA) colorectal cancer screening test. News release. Geneoscopy. May 6, 2024. Accessed May 7, 2024. https://www.geneoscopy.com/fda-approves-colosense-geneoscopys-noninvasive-multi-target-stool-rna-mtrna-colorectal-cancer-screening-test/
2. Geneoscopy submits premarket approval application to FDA for its noninvasive colorectal cancer RNA biomarker screening test. News release. Geneoscopy. January 24, 2023. Accessed May 7, 2024. https://www.geneoscopy.com/geneoscopy-submits-premarket-approval-application-to-fda-for-its-noninvasive-colorectal-cancer-rna-biomarker-screening-test/
3. Barnell EK, Wurtzler UM, 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
4. Hyams T, Mueller N, Curbow B, Kig-Narshall E, Sultan S. Screening for colorectal cancer in people ages 45-49: research gaps, challenges and future directions for research and practice. Translat Behav Med. 2022;12(2):198–202. doi:10.1093/tbm/ibab079