Geneoscopy, a life sciences company focused on the development of diagnostic tests for gastrointestinal health, submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its noninvasive, stool-based, at-home screening test to detect colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals.
The FDA designated the test as a Breakthrough Device in January 2021.
“Over 50 million Americans between the ages of 45 and 85 are eligible to be screened for CRC.1,2 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,” says Erica Barnell, MD, PhD, chief science officer and Geneoscopy’s co-founder. “We are committed to closing this gap for patients who require screening and look forward to working with the FDA to bring a convenient and reliable screening option to patients that may allow for earlier detection and treatment—and potentially save lives.”
The PMA submission is based on results from the pivotal CRC-PREVENT trial, in which Geneoscopy’s test demonstrated 94% sensitivity for CRC and 45% sensitivity for advanced adenomas.
Additionally, in the 45-49 age population, Geneoscopy’s test demonstrated 100% sensitivity for cancer and 44% sensitivity for advanced adenomas, at an 89% specificity.
“The completion of our PMA submission is a major milestone – Geneoscopy’s first regulatory approval application,” says Andrew Barnell, CEO and Geneoscopy’s co-founder. “This product and the years of effort from our team that have brought us here exemplify the dedication to our mission to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The impact this test can have on patient health is beyond exciting, as is the validation of our stool RNA platform. We believe this platform will yield additional tests, including increasingly more precise CRC screening and high-value diagnostic testing for other gastrointestinal indications.”
- Colorectal Cancer Screening in U.S. Seniors ages 76-84 Years. (2016, August 1). NCBI. Retrieved January 19, 2023, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4491009/
- Estimating the Screening-Eligible Population Size, Ages 45-74, at Average Risk to Develop Colorectal Cancer in the United States. (n.d.). PubMed. Retrieved January 19, 2023, from https://pubmed.ncbi.nlm.nih.gov/32029430/
Featured image: CRC-PREVENT Key Trial Results. Photo: Geneoscopy