Geneoscopy, a life sciences company focused on the development of diagnostic tests for gastrointestinal health, announced results of a large clinical trial evaluating the efficacy of its noninvasive, stool-based, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals.
In the CRC-PREVENT trial, Geneoscopy’s stool-based screening test met the clinical endpoints across all primary outcome measures, including sensitivity and specificity for colorectal cancer and advanced adenomas.
The CRC-PREVENT trial included 8,289 individuals with diverse racial, ethnic, and socioeconomic backgrounds across more than 2,900 zip codes in all lower 48 states, with colonoscopies performed in more than 3,800 endoscopy centers, which reflect the diversity of gastroenterology practices across America. Efficacy results from the study include:
- 94% sensitivity for detecting CRC
- 45% sensitivity for detecting AA
- 88% specificity for no findings on a colonoscopy
These sensitivity results are some of the highest reported for any noninvasive colorectal cancer screening test in any prospective registrational clinical study completed to date. Of note, CRC-PREVENT is the first prospective clinical study wherein a stool-based test demonstrated the ability to detect CRC amongst 45-49-year-olds in a U.S. population.1 Additionally, CRC and AA sensitivity performance results for Geneoscopy’s test exceed those recently reported from a large clinical study for a blood-based test.2 Moreover, a recent study suggests, when given a choice, patients are more willing to comply with a stool-based screening test than a blood-based test. This was primarily attributed to the greater ability to complete a stool test at home.3
Geneoscopy’s test, performed in its St. Louis laboratory, 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 granted the test its Breakthrough Designation in January 2021.
“The use of our patented RNA biomarker technology is a first in CRC screening. The large-scale prospective clinical study data demonstrate 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,” says Erica Barnell, MD, PhD, chief science officer and co-founder of Geneoscopy.”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.”
Despite colorectal cancer being this country’s second leading cause of cancer death, millions of eligible Americans do not get screened – many due to a lack of access or avoidance of invasive options like colonoscopies.
“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,” says David Lieberman, MD, professor of medicine, Division of Gastroenterology and Hepatology, Oregon Health Sciences University School of Medicine, and past president of the American Gastroenterology Association.4 “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.”
Geneoscopy’s test is not yet available for sale and is not yet approved by the U.S. Food and Drug Administration (FDA). A Premarket Approval submission to the FDA is planned for the first quarter of 2023.
- Thomas F. Imperiale, John B. Kisiel, Steven H. Itzkowitz, Bradley Scheu, Emma Kate Duimstra, Sandra Statz, Barry M. Berger, Paul J. Limburg; Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45–49 Year-Olds: A Cross-Sectional Study. Cancer Prev Res (Phila) 1 April 2021; 14 (4): 489–496. https://doi.org/10.1158/1940-6207.CAPR-20-0294
- Guardant. (2022, December 15). Guardant Health announces positive results from pivotal ECLIPSE study evaluating a blood test for the detection of colorectal cancer [Press release.] Retrieved from: https://investors.guardanthealth.com/press-releases/press-releases/2022/Guardant-Health-announces-positive-results-from-pivotal-ECLIPSE-study-evaluating-a-blood-test-for-the-detection-of-colorectal-cancer/default.aspx
- Young GP, Chen G, Wilson CJ, et al. “Rescue” of Nonparticipants in Colorectal Cancer Screening: A Randomized Controlled Trial of Three Noninvasive Test Options. Cancer Prev Res (Phila). 2021;14(8):803-810. doi:10.1158/1940-6207.CAPR-21-0080
- Dr. David Lieberman is a member of Geneoscopy’s Scientific Advisory Board.