NEW YORK – Gastrointestinal health diagnostics company Geneoscopy said on Tuesday that it has closed a Series B financing round, raising $105 million through a combination of debt and equity.
The round was led by previous investors Lightchain Capital and NT Investments, and included Morningside Ventures, Labcorp, Cultivation Capital, BioGenerator Ventures, and Innovatus Capital Partners.
Geneoscopy said it plans to use the funds to support a study of ColonoSight — its multi-target stool RNA test for colorectal screening — as well as to scale commercial infrastructure, and expand its diagnostic product pipeline.
The trial, CRC-PREVENT, will be used for the clinical validation of ColonoSight. Geneoscopy is positioning the test as a direct competitor to diagnostics like Exact Sciences' Cologuard and is evaluating the test's safety and efficacy in average-risk individuals with no known comorbidities associated with cancer risk before pursuing approval from the US Food and Drug Administration.
The prospective, single-arm study began enrolling patients in July. The company is aiming to enroll more than 12,000 patients across all 48 contiguous US states. Patients will submit their samples through the mail and will subsequently undergo optical colonoscopies. All significant lesions discovered during the colonoscopies will be biopsied or removed and sent for histopathology. Researchers will then conduct a comparative analysis to determine sensitivity and specificity for colorectal cancer, advanced adenomas, non-advanced adenomas, benign hyperplastic polyps, and colonoscopies without findings.
ColonoSight received breakthrough device designation from the FDA in January 2020.
Geneoscopy cofounder and CEO Andrew Barnell said in a statement that the financing reflects investors' confidence in Geneoscopy's "ability to address the significant unmet need within the colorectal cancer screening market for a noninvasive means to not only accurately detect cancer at an early stage, but also advanced adenomas."
Geneoscopy's multifactor assay combines eight stool-derived eukaryotic RNA biomarkers, patient demographic information such as smoking status, and a fecal immunochemical test, or FIT, to detect cancerous lesions. According to company CSO Erica Barnell, the focus on RNA rather than DNA makes Geneoscopy's test much better than similar tests at detecting the high-risk adenomas that are most dangerous to patients, given their high malignancy transformation rates of up to 30 percent to 50 percent per year.