Clinical Trial Confirms Highest Reported Sensitivity Results for At-Home, Noninvasive Colorectal Cancer Screening Test

The stool-test is the first-of-its-kind to detect CRC in adults aged 45 to 49 years, with a premarket approval submission planned to be sent to the FDA early in 2023.

A new noninvasive, stool-based, at-home diagnostic screening test (Geneoscopy) has been shown to detect colorectal cancer (CRC) with 94% sensitivity, based on the results of the CRC-PREVENT trial. It relies on a novel method of stabilizing and extracting eukaryotic RNA biomarkers to improve diagnosis.

"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 [AA] that put them at higher risk of developing cancer,” said Erica Barnell, chief science officer and co-founder of Geneoscopy, in the recent press release.

The test, which can also detect AA, meets all clinical endpoints. It now has the highest reported sensitivity results of any noninvasive CRC screening test among those in prospective registrational clinical studies.

Colonoscopies are a gold standard in CRC screening, but the bowel preparation, sedation, and time away from work can discourage patients from the screening. Because of these challenges, current noninvasive screening kits are available, although many remain less sensitive at detecting early-stage CRC and AAs, which is a type of high-risk lesion, that occur in 95% of CRC cases.

“If we can identify patients with AAs and remove those lesions, many cancers can be prevented,” David Lieberman, a professor of medicine, Division of Gastroenterology and Hepatology, Oregon Health Sciences University School of Medicine, and former president of the American Gastroenterology Association, said in the press release.

Lieberman also notes that less individuals were screened during the pandemic, calling for the need of an effective, noninvasive screening option.

The CRC-PREVENT trial, a phase 3 prospective, single-arm study, evaluated the efficacy of the noninvasive and at-home diagnostic screening test for CRC/AA detection in 8289 racially, ethnically, and socioeconomically diverse individuals with average-risk who are aged 45 years and older. During the trial, the patients’ self-collected stool samples using the screening kit and sent them in to the lab for analysis. Some patients opted to receive a colonoscopy as well—for these patients, researchers then compared the colonoscopy and at-home kit results to measure the kit’s efficacy at detecting CC, AA, non-advanced adenomas, and benign hyperplastic polyps, as well as a potential lack of findings.

Researchers found that the self-collecting kit had almost perfect sensitivity for CRC detection, 45% sensitivity with AA, and 88% specificity for no findings on a colonoscopy, “provide(-ing) further evidence that our test may allow patients to get appropriate treatment, in some cases, even before cancer develops,” Barnell said.

More than 50,000 individuals die from CRC each year, making it the number 2 leading cause of death from cancer in the United States. Survival is best with early detection, but many individuals are diagnosed at a fatally advanced stage.

“I'm hoping to have a new and highly reliable test available for patients soon,” said Lieberman in the press release. ”One that will allow them to conveniently screen for CRC in their own homes."

Reference

Geneoscopy Inc. Geneoscopy’s Noninvasive Colorectal Cancer Screening Test Demonstrates High Sensitivity and Specificity in Large Pivotal Clinical Trial. January 10, 2023. Accessed on January 11, 2023. https://www.geneoscopy.com/

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