On January 10, 2023 Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, reported it favorable results from the CRC-PREVENT trial – a pivotal 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 (Press release, Geneoscopy, JAN 10, 2023, View Source [SID1234626168]). In the trial, Geneoscopy’s stool-based screening test met the clinical endpoints across all primary outcome measures, including sensitivity and specificity for CRC and AA.
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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 the highest reported for any noninvasive CRC 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 US 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
Importantly, given Geneoscopy’s decentralized clinical trial approach, the demographics of the patients who enrolled and completed the CRC-PREVENT study are more reflective of the socioeconomic and racial diversity of the country than most conventional, centralized trials. The diversity of the patient cohort confirms the test’s performance across different demographic groups and advances the important goal of increased access to healthcare innovation for historically underserved populations.
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," said Dr. Erica Barnell, Chief Science Officer and Geneoscopy’s co-founder. "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 CRC 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," noted Dr. David Lieberman, 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.
About CRC-PREVENT
CRC-PREVENT was a Phase 3 prospective, single-arm study designed to evaluate the efficacy of Geneoscopy’s noninvasive, at-home diagnostic screening test to detect colorectal cancer and advanced adenomas in average-risk individuals aged 45 years and older. Using a collection kit, participants submitted self-collected stool samples via express delivery and underwent an optical colonoscopy examination. All significant lesions discovered during the colonoscopy were biopsied or removed and sent for histopathology. A comparative analysis was conducted to determine sensitivities and specificities for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies with no findings.
About Colorectal Cancer & Screening
Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S. Yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and potential time away from work. Currently available noninvasive screening methods demonstrate lower sensitivity to detect early-stage CRC and high-risk precancerous lesions, including advanced adenomas, which are estimated to be a precursor in 95 percent of CRC cases.