A stool-based, non-invasive, at-home colorectal cancer and advanced adenoma test showed a strong ability to detect disease, according to updated trial results.
Investigators reported that a stool-based, non-invasive, at-home test aimed at detecting colorectal cancer (CRC) and advanced adenomas yielded high sensitivity and specificity results, according to a press release from Genescopy.
The results came from the phase 3 CRC-PREVENT trial (NCT04739722) which identified a sensitivity of 94% in detecting CRC, a sensitivity of 45% in detecting advanced adenomas, and a specificity of 88% for no findings on the colonoscopy.
Investigators noted that these are some of the highest sensitivity data from a prospective, registrational study that have been observed with a noninvasive CRC screening test.
“The use of our patented RNA biomarker technology is a first in CRC screening,” Erica Barnell, MD, PhD, co-founder and chief science officer at Geneoscopy, said in the press release. “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.”
A total of 8289 patients were included in the study and were representative of 48 states. The trial included 3800 endoscopy centers, demonstrating the diversity of gastroenterology clinics within the United States.
The study included average-risk individuals who were 45 years or older. Patients used a collection kit to collect stool samples and submit them for analysis with express delivery. From there, the individuals received an optical colonoscopy exam.
If any significant lesions were found during the exam, a biopsy was performed and sent for histopathology.
A comparative analysis was performed to assess sensitivity and specificity for CRC, advance adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies where no findings were reported.
The patient population was more reflective of the racial and socioeconomic backgrounds of the U.S. population. Due to this diversity, investigators noted that this confirms the test’s efficacy in different patient subgroups in addition to making health care more accessible to populations that are historically underserved.
The test received breakthrough therapy designation in January 2021 and the premarket approval submission is planned for early Q1 2023.
“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,” David Lieberman, MD Professor of Medicine, Division of Gastroenterology and Hepatology, Oregon Health Sciences University School of Medicine, and previous president of the American Gastroenterology Association, concluded. “If we can identify patients with advanced adenomas and remove those lesions, many cancers can be prevented.”
Geneoscopy’s Noninvasive Colorectal Cancer Screening Test Demonstrates High Sensitivity and Specificity in Large Pivotal Clinical Trial. News release. Geneoscopy. January 10, 2022. Accessed January 10, 2022. https://bit.ly/3W0KaoL