Life sciences firm Geneoscopy has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for a stool-based, at-home screening test to detect colorectal cancer (CRC) and advanced adenomas in average-risk individuals.
The PMA submission is based on results from a pivotal clinical trial called CRC-PREVENT in which the test showed 94% sensitivity in detecting CRC and 45% sensitivity in detecting advanced adenomas.
In the adult population comprising individuals ages 45 to 49, the test demonstrated 100% sensitivity for cancer and 44% sensitivity for advanced adenomas at 89% specificity, according to Geneoscopy.
The FDA granted a breakthrough device designation for the company's RNA biomarker screening test in January 2021.
"Over 50 million Americans between the ages of 45 and 85 are eligible to be screened for CRC,” Dr. Erica Barnell, chief science officer and co-founder of Geneoscopy, said in a statement. “Unfortunately, despite CRC being the second leading cause of cancer death in the U.S., millions of eligible Americans do not get screened -- many due to a lack of knowledge of the importance of screening, lack of access to screening, and concerns about the invasive nature of options like colonoscopy.”