FDA Oks ColoSense, a Stool Test for Early Colorectal Cancer Detection

• The FDA approved ColoSense™, a noninvasive stool test for colorectal cancer (CRC) screening in average-risk adults 45 and older.
• It detects cancer with 93% accuracy and may improve early detection rates.
• Data from the phase 3 CRC-PREVENT trial (NCT04739722) support this regulatory decision.

The FDA has granted approval to a noninvasive, multitarget stool RNA screening test called ColoSense™ for use in adults aged 45 years or older who are at average risk of developing CRC, according to Geneoscopy, Inc.¹

ColoSense™ is a screening test which aims to detect colorectal neoplasia-associated RNA markers and occult hemoglobin in human stool. If a ColoSense™ result is positive, this could mean CRC, advanced adenomas (AAs), or serrated precancerous lesions, are present. Following the positive result, patients should receive a colonoscopy.

Findings from the phase 3 CRC-PREVENT trial support this regulatory decision as in the study, ColoSense™ demonstrated a 93% sensitivity for detecting CRC. The test also identified 100% of stage I CRC and detected 45% of AAs. Notably, the CRC and AA sensitivities were 100% and 44%, respectively, in patients between 45 and 49 years of age.

“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, chief executive officer and cofounder of Geneoscopy, in a press release. “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.”

Data from the CRC-PREVENT study were previously published in The Journal of the American Medical Association.² Social media platforms were utilized to identify and enroll patients from June 2021 to June 2022 using a decentralized nurse call center. Enrollment was open to male and female patients who were over 45 years old and willing to provide stool samples within 120 days before a colonoscopy.³

Colorectal Cancer: © peterschreiber.media - stock.adobe.com

In the CRC-PREVENT study, experts assessed over 1800 average-risk individuals aged 45 to 49. These individuals represented over 20% of participants on the trial.¹

Patients were required to complete the multitarget RNA test, including a commercially available FIT, a concentration of 8 RNA transcripts, and participant-reported smoking status, and patients underwent a colonoscopy at their local endoscopy center once stool samples were completed. Those included in the trial ended up having a mean age of 55 years (range, 45-90), and 4%, 11%, and 7% of participants self-identified as Asian, Black, and Hispanic, respectively.²

The sensitivity of ColoSense™ for detecting CRC and AAs and the specificity for detecting no lesions on colonoscopy were the primary end points of the study.

Of the 8920 patients eligible for the study, 0.40% had CRC and 6.8% had AAs. A sensitivity of 94% for detecting CRC, 46% for detecting AAs, and 88% for no lesions on colonoscopy was shown by ColoSense™. Additionally, ColoSense™ led to an improved sensitivity for CRC (94% vs 78%; McNemar P =.01) and AAs (46% vs 29%; McNemar P <.001) compared with a commercially available fecal immunochemical test (FIT).²

As stated in the press release, ColoSense™ is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.¹

“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,” said Anjee Davis, president of Fight CRC, added 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 colorectal cancer diagnoses.”

REFERENCES:

1. FDA approves ColoSense™ - Geneoscopy's noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test. News release. Geneoscopy. May 6, 2024. Accessed May 7, 2024. https://tinyurl.com/5n8hwx4t

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

3. Colorectal cancer and pre-cancerous adenoma non-invasive detection test study (CRC-PREVENT). ClinicalTrials.gov. Updated May 15, 2023. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04739722