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St. Louis gastrointestinal health startup Geneoscopy has received U.S. Food and Drug Administration approval for the screening test it has developed to detect colorectal cancer.
Geneoscopy, with the FDA approval, said it plans to commercially launch its screening test later this year or in early 2025. The test, called ColoSense, is a preventive, stool-based test designed to detect colon cancer in those 45 years or older.
“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting colorectal cancer and advanced adenomas,” Andrew Barnell, co-founder and CEO of Geneoscopy, said in a statement. “This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”
Founded in 2015, Geneoscopy has raised more than $100 million in financing as it's sought to bring its colorectal cancer screening test to market. It also has pursued having its technology used to detect other diseases.
Geneoscopy in January 2023 released results of its clinical trial for its colorectal cancer screening test, saying it “can accurately detect if people have cancer and if they have advanced adenomas that put them at higher risk of developing cancer.” Results reported by Geneoscopy said the study found its test had 93% sensitivity for detecting colorectal cancer and 45% sensitivity for detecting advanced adenomas.
Geneoscopy has partnered with Labcorp (NYSE: LH) to distribute ColoSense to health care providers as part of their patient screening programs. The agreement partners Geneoscopy with a major laboratory and diagnostics firm, with Burlington, North Carolina-based Labcorp having more than 67,000 employees and $12.2 billion in 2023 revenue.
The FDA approval for ColoSense comes as Geneoscopy faces litigation from a competitor. Exact Sciences (NASDAQ: EXAS), the maker of the Cologuard screening test for colorectal cancer, in November said it sued Geneoscopy for patent infringement. Geneoscopy in December filed a motion seeking to have the lawsuit be dismissed. The startup Tuesday said in a statement it “continues to believe that the claims made in the litigation are without any merit.”
Geneoscopy has 55 employees, with more than half of its workers based in St. Louis, where its headquarters is at 2220 Welsch Industrial Court. The company said it plans to add staff as it works toward commercialization of ColoSense. It is currently hiring for a director of market access.