FDA Approves Noninvasive Stool RNA Test for Colorectal Cancer Screening

Investigators evaluated the sensitivity and specificity of ColoSense compared with a colonoscopy among individuals who were at risk for CRC in the phase 3 CRC-PREVENT trial (NCT04739722).

The FDA has granted approval to ColoSense—a noninvasive, multitarget stool RNA test—as a screening tool for individuals 45 years and older who are at average risk of having colorectal cancer (CRC), according to a press release from the developers, Geneoscopy, Inc.¹

Geneoscopy noted that the regulatory agency designated ColoSense as a Breakthrough Device. The tool is the first noninvasive CRC screening test to make use of RNA biomarkers to help observe disease activity in this patient population.

“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. 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,” Andrew Barnell, chief executive officer and co-founder at Geneoscopy, said in the press release.¹

Investigators evaluated the sensitivity and specificity of ColoSense compared with a colonoscopy among individuals who were at risk for CRC in the phase 3 CRC-PREVENT trial (NCT04739722).

According to data published in JAMA, ColoSense demonstrated a sensitivity of 94.4% (95% CI, 81%-99%) for detecting CRC.² Additionally, the sensitivity of the test when detecting advanced adenomas was 45.9% (95% CI, 42%-50%). Investigators also reported a specificity of 87.9% for no lesions on colonoscopy.

Findings highlighted that ColoSense demonstrated improvements in sensitivity compared with a commercially available fecal immunochemical test in CRC (94.4% vs 77.8%; McNemar P = .01) and advanced adenomas (45.9% vs 28.9%; McNemar P <.001).

Of all patients with detected CRC, 47% were 54 years or younger. Among patients who were 45 to 49 years old, the detection rate of CRC with ColoSense was 100% (n = 5), and the detection rate for advanced adenomas was 45% (n = 103).

“The [multitarget stool RNA] test can be an effective noninvasive test that is sensitive for [CRC] and advanced adenomas, with a comparable level of false-positive results compared with existing molecular screening tests,” the study authors wrote.² “Also, the use of social media could potentially identify individuals not actively participating in [CRC] screening to potentially improve screening rates for this patient population.

In the blinded, prospective, cross-sectional CRC-PREVENT study, 8920 individuals underwent testing with ColoSense. Investigators collected stool samples before individuals underwent a colonoscopy at their local endoscopy center. Moreover, test results with ColoSense were then compared with index lesions that investigators observed via colonoscopy.

The mean age among individuals enrolled on the study was 55 years (range, 45-90). Additionally, 60% of the population was female. Most individuals identified themselves as White (84%) followed by Black (11%), Hispanic (7%), and Asian (4%). Investigators reported that 34% of those enrolled on the study had an annual household income of less than $50,000 per year. Additionally, 30% had public insurance or no insurance, and 5% resided in rural areas. Moreover, 34% had prior exposure to tobacco products, while 7% reported a history of CRC in a first-degree relative.

“The growing number of adults diagnosed with [CRC] 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 release.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 [CRC] diagnoses.”

References

1. FDA approves ColoSense™ – Geneoscopy's noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test. News release. Geneoscopy, Inc. May 6, 2024. Accessed May 7, 2024. https://tinyurl.com/ypyunvt9
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