FDA Receives Premarket Approval Application for Noninvasive CRC Screening Test

Geneoscopy has submitted a premarket approval application (PMA) to the FDA for a noninvasive, stool-based, at-home screening test to detect colorectal cancer (CRC) and advanced adenomas in average-risk individuals, according to an announcement from the company.¹

The application is based on data from the phase 3 CRC-PREVENT trial (NCT04739722), which met its primary objectives for sensitivity and specificity.² The screening test delivered a 94% sensitivity for detecting CRC, a 45% sensitivity for detecting advanced adenomas, and an 88% specificity for no findings on a colonoscopy.

Additionally, in the population of participants between 45 and 49 years of age, the test demonstrated 100% sensitivity for CRC and 44% sensitivity for advanced adenomas, at an 89% specificity.¹

“The completion of our PMA submission is a major milestone – Geneoscopy’s first regulatory approval application,” Andrew Barnell, chief executive officer and co-founder of Geneoscopy, stated in a news release. “This product and the years of effort from our team that have brought us here exemplify the dedication to our mission to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The impact this test can have on patient health is beyond exciting, as is the validation of our stool RNA platform. We believe this platform will yield additional tests, including increasingly more precise CRC screening and high-value diagnostic testing for other gastrointestinal indications.”

The at-home screening test uses a novel, proprietary method to stabilize and extract eukaryotic RNA biomarkers from stool samples that may allow for improved diagnosis and management of gastrointestinal diseases, such as CRC. The FDA previously granted a breakthrough designation to the test in January 2021.

The prospective phase 3, single-arm CRC-PREVENT trial evaluated the efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to detect CRC and advanced adenomas in average-risk adults aged 45 years and older.

The study enrolled 8289 participants from diverse racial, ethnic, and socioeconomic backgrounds in all 48 contiguous states, and colonoscopies were conducted at more than 3800 endoscopy centers.

Candidates were excluded from the trial if they had any precancerous findings on their most recent colonoscopy, a history or diagnosis of CRC, a history of aerodigestive tract cancer, a colonoscopy in the previous 9 years, or a prior colorectal resection for any reason other than sigmoid diverticular disease.³

Participants who enrolled received a collection kit and submitted self-collected stool samples before undergoing an optical colonoscopy examination within 120 days. All significant lesions discovered during the colonoscopy were biopsied or removed and sent for histopathology.

A comparative analysis was then conducted to determine sensitivities and specificities for CRC, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies with no findings.

References

1. Geneoscopy submits premarket approval application to U.S. Food and Drug Administration for its noninvasive colorectal cancer RNA biomarker screening test. News release. Geneoscopy. January 24, 2023. Accessed January 24, 2023. http://bit.ly/3XAIjIP
2. Geneoscopy’s noninvasive colorectal cancer screening test demonstrates high sensitivity and specificity in large pivotal clinical trial. News release. Geneoscopy. January 10, 2023. Accessed January 24, 2023. https://bit.ly/3XiyTkT
3. Colorectal cancer and pre-cancerous adenoma non-invasive detection test study (CRC-PREVENT). ClinicalTrials.gov. Updated August 26, 2022. Accessed January 24, 2023. https://clinicaltrials.gov/ct2/show/NCT04739722