Geneoscopy released results from a broad clinical study that puts the startup one step closer to commercializing a product.
Erica Barnell, Geneoscopy CTO
“We look forward to submitting a Premarket Approval application to the FDA,” CSO Erica Barnell said in a release. PMA is a scientific, regulatory documentation to the FDA to demonstrate the safety and effectiveness of a Class III device. “The large-scale prospective clinical study data demonstrate that this noninvasive (colorectal cancer) screening test can accurately detect if people have cancer and if they have advanced adenomas that put them at higher risk of developing cancer.”
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. (Note: the Barnells are brother and sister.)
The study:
- 8289 participants
- 94% sensitivity for detecting CRC
- 45% sensitivity for detecting AA
- 88% specificity for no findings on a colonoscopy
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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