Genoscopy Data Good, But Tough Hill to Climb Commercially Given Next Generation ColoGuard Test is More Accurate
Geneoscopy Inc. announced the publication of its pivotal CRC-PREVENT trial results. The results of the CRC-PREVENT trial, are set to be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, Canada, The study evaluated 8,920 participants aged 45 and older using Geneoscopy’s multi-target stool RNA (mt-sRNA) test. The test demonstrated a 94% sensitivity in detecting CRC, including 100% sensitivity for early-stage (Stage I) CRC and a 46% sensitivity in detecting advanced adenomas, which increased to 50% for adenomas over two centimeters in size. The specificity for Genoscopy’s test was 88%. In general, while the results are favorable, they were not as good as the data presented on competitor Exact Sciences’ second generation test, especially for precancerous adenomas. This likely creates a challenging path for Genoscopy to make significant inroads given Exact Sciences strong commercial team and significant adoption to date. However, increased competition could have an impact on pricing power for Exact Sciences. In other laboratory developed tests markets such as non-invasive prenatal screening and hereditary cancer the advent of competitors has led to pricing erosion for the market incumbent as payers threaten in-network status to achieve pricing concessions.
Geneoscopy has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for its noninvasive, multi-target stool RNA (mt-sRNA) colorectal cancer screening test.
Dr. David Lieberman, co-author of the study and a faculty member at Oregon Health & Science University, emphasizes the significance of these findings, stating, “Geneoscopy’s technology can potentially provide millions of people with a convenient and reliable option for detecting and preventing CRC.”