FDA Approves ColoSense, a Noninvasive mt-sRNA Test, for Adults 45 or Older

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Geneoscopy's ColoSense received FDA approval on May 06, 2024 based on data from the phase 3 CRC-PREVENT trial.

US FDA logo in black over a white background. | Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

The US Food and Drug Administration has approved ColoSense, a noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test, for use as a screening test in adult patients aged 45 years or older considered to be at average risk for develop colorectal cancer.

Announced by Geneoscopy on May 06, 2024, the approval is based on data from the pivotal CRC-PREVENT trial and Geneoscopy expects availability of ColoSense to begin in late 2024 or early 2025.1

“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,” said Anjee Davis, president of Fight CRC.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.”

Check out our recent discussion on updates in colorectal cancer screening from Colorectal Cancer Awareness Month.

The second leading cause of cancer-related death in the US, the growing prevalence of colorectal cancer, particularly in younger patient populations, has thrust discussions around screening to the forefront of public health discussions in recent years. Geneoscopy’s development of the ColoSense screening test was based in their desire to provide additional noninvasive testing options, with the possibility of greater sensitivity than currently available tests.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. Per trial protocol, all participants completed the mt-sRNA test, which incorporated a commercially available fecal immunochemical test (FIT), concentration of 8 RNA transcripts, and participant-reported smoking status. Investigators pointed out stool samples were collected prior to participants completing a colonoscopy at their local endoscopy center.2

The study cohort had a mean age of 55 (range, 45-90) years. Among the 8920 included, 4% self-identified as Asian, 11% as Black, and 7% as Hispanic. Investigators pointed out 36 (0.40%) had colorectal cancer and 606 (6.8%) had advanced adenomas.2

For the purpose of analysis, positive or negative my-sRNA test results were compared with index lesions observed on colonoscopy. The primary outcomes of interest for the trial were the sensitivity of the mt-sRNA test for detecting colorectal cancer and advanced adenomas and the specificity for no lesions on colonoscopy.2

Results of the study suggested the mt-sRNA test sensitivity for detecting colorectal cancer was 94%, sensitivity for detecting advanced adenomas was 46%, and specificity for no lesions on colonoscopy was 88%. Additional analysis revealed the mt-sRNA test showed significant improvement in sensitivity for colorectal cancer (94% vs 78%; McNemar P = .01) and advanced adenomas (46% vs 29%; McNemar P <.001) compared with results of the FIT.2

“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy.1 “This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”

References:

  1. Pretto J. FDA approves ColoSenseTM - Geneoscopy’s noninvasive multi-target stool RNA (MT-SRNA) colorectal cancer screening test - geneoscopy - transforming gastrointestinal health. 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. 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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