Mere days after releasing it’s comprehensive study (see bizblip Jan. 10 article) Geneoscopy petitioned the FDA for Premarket Approval of its at-home stool testing kit.
“The completion of our PMA submission is a major milestone – Geneoscopy’s first regulatory approval application,” CEO Andrew Barnell said in a release. “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 company is developing a screening methodology to noninvasively diagnose colorectal cancer using bio-markers in stool samples. The screening technology examines RNA in a stool sample to detect the cancer, but this simple test is just the first of what CEO Andrew Barnell told bizblip last year will be a platform of tests. Broadening this technology could be used to detect, prevent, and guide treatment of a wide variety of gastrointestinal diseases. The St. Louis-based Geneoscopy was founded in 2015.
The company has 50 full time employees, mostly scientists. Last November it closed a $105M Series B led by Lightchain Capital and NT Investments with participation from Morningside Ventures, Labcorp, Cultivation Capital, BioGenerator Ventures and Innovatus Capital Partners. Prior to that, it raised a total of $7.9M, mostly from a 2019 Series A. Other investors include Missouri Technology Corporation, Billiken Angels Network, the Dorm Room Fund and individual investor Rodger Riney.
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