ColoSense detects CRC, advanced adenomas with sensitivities of 94%, 46%
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Key takeaways:
- Sensitivities for detecting CRC and advanced adenomas using the multitarget stool RNA test were 94% and 46%, respectively.
- Specificity for no lesions on colonoscopy was 88%.
The ColoSense multitarget stool RNA test demonstrated high sensitivity for detection of colorectal cancer and advanced adenoma, notably in individuals aged 45 to 49 years, according to data in JAMA.
“There are currently no approved or cleared RNA-based molecular tests for the detection of CRC or advanced adenomas in average-risk individuals, prompting the need to provide a more convenient, noninvasive option for CRC screening,” Erica K. Barnell, MD, PhD, chief science officer and co-founder at Geneoscopy, told Healio. “Additionally, there is a notable gap in data regarding the efficacy of noninvasive screening tests for the younger age group.”
She added, “By providing a noninvasive RNA-based test for individuals, we can improve screening compliance and stratify risk for individuals requiring invasive procedures, such as colonoscopy, to remove lesions.”
In the prospective, cross-sectional phase 3 CRC-PREVENT trial, Barnell and colleagues enrolled 8,920 participants (mean age, 55 years; 60% women) from June 2021 to June 2022 to evaluate the sensitivity and specificity of the multitarget stool RNA (mt-sRNA) ColoSense test (Geneoscopy) vs. colonoscopy.
All participants completed the test, which incorporated a fecal immunochemical test and concentration of eight RNA transcripts, as well as participant-reported smoking status; all stool samples were collected prior to colonoscopy.
“At the time of enrollment, 70% had never before been screened with a colonoscopy and did not have a colonoscopy scheduled, which permitted enrollment of individuals who were not yet actively participating in colorectal cancer screening modalities,” Barnell noted. “In total, 85% of subjects successfully submitted a viable ColoSense test to our laboratory and about 85% of those were successfully navigated to a colonoscopy.”
Studied outcomes included sensitivity of the mt-sRNA test for detecting CRC and advanced adenomas as well as specificity for no lesions on colonoscopy.
Results showed 0.4% of participants had CRC, 6.8% had advanced adenomas, 7.3% had medium-risk adenomas and 25.6% had low-risk adenomas. Across all eligible participants, the adenoma detection rate was 40.1%.
“In terms of sensitivity and specificity, the ColoSense test showed impressive results when compared to colonoscopy,” Barnell told Healio.
Sensitivities for detecting CRC and advanced adenomas using the mt-sRNA test were 94% and 46%, while specificity for no lesions on colonoscopy was 88%. Results also showed “significant improvement” in sensitivity for CRC (94% vs. 78%) and advanced adenomas (46% vs. 29%) compared with FIT.
“Notably, for younger participants ages 45 to 49, CRC sensitivity was 100% and [advanced adenoma] sensitivity was 45%,” Barnell said. “This is in direct contrast to other methylation-based assays, which incur a significant degradation in sensitivity when evaluating patients in younger age groups.”
Barnell continued: “This provides robust evidence that our test can effectively screen patients in the 45 to 50 age range noninvasively, offering a valuable option for early detection in this population.”
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