At-Home Screening Test Demonstrates Sensitivity, Specificity in Detecting CRC

David Lieberman, MD

Geneoscopy’s at-home, stool-based diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas in average-risk individuals displayed high sensitivity and specificity, meeting the primary objectives of the phase 3 CRC-PREVENT trial (NCT04739722).¹

Findings showed that the screening test produced a 94% sensitivity for detecting CRC, a 45% sensitivity for detecting advanced adenomas, and an 88% specificity for no findings on a colonoscopy. Geneoscopy plans to file a premarket approval application to the FDA in the first quarter of 2023.

The 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. In January 2021, the FDA granted a breakthrough designation to the test.

“The use of our patented RNA biomarker technology is a first in CRC screening. The large-scale prospective clinical study data demonstrates that this noninvasive CRC screening test can accurately detect if people have cancer and if they have advanced adenomas that put them at higher risk of developing cancer. These results provide further evidence that our test may allow patients to get appropriate treatment, in some cases, even before cancer develops,” Erica Barnell, MD, PhD, chief science officer and co-founder of Geneoscopy, stated in a news release. “Our sincerest gratitude goes to all who participated in or were involved with this trial. We look forward to submitting a premarket approval application to the FDA to make this cutting-edge innovation available to the millions of Americans eligible to be screened for CRC.”

The CRC-PREVENT trial included 8289 participants from diverse racial, ethnic, and socioeconomic backgrounds in all 48 contiguous states. Investigators conduced colonoscopies at more than 3800 endoscopy centers.

The prospective phase 3, single-arm study 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.

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.²

Enrolled participants 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. Investigators then conducted a comparative analysis to determine sensitivities and specificities for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies with no findings.

“Colonoscopy screening rates declined during the pandemic, stressing the need for noninvasive screening options. That’s why noninvasive tests, allowing for collection to be done at home, have become a critical tool in the battle against CRC, as they make screening easier and more accessible,” said David Lieberman, MD, a professor of Medicine in the Division of Gastroenterology and Hepatology at Oregon Health Sciences University School of Medicine, and the past president of the American Gastroenterology Association.

“Geneoscopy’s test and the positive clinical trial results are promising because patients need additional convenient options that will accurately detect colon cancer, as well as advanced adenomas, before patients have cancer. If we can identify patients with advanced adenomas and remove those lesions, many cancers can be prevented. I’m hoping to have a new and highly reliable test available for patients soon—one that will allow them to conveniently screen for CRC in their own homes.”

References

1. 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 10, 2023. https://bit.ly/3XiyTkT
2. Colorectal cancer and pre-cancerous adenoma non-invasive detection test study (CRC-PREVENT). ClinicalTrials.gov. Updated August 26, 2022. Accessed January 10, 2023. https://clinicaltrials.gov/ct2/show/NCT04739722