ST. LOUIS– Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced a strategic collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services. This multi-year agreement will increase access to Geneoscopy’s next-generation colorectal cancer screening test, which offers at-home collection and high sensitivity for early cancer detection. Geneoscopy’s test is under FDA review. Once approved by the FDA, Labcorp will offer the test, which will be performed by Geneoscopy, enabling health care customers to conveniently order it through Labcorp as part of their comprehensive screening programs.
“Colorectal cancer is one of the most preventable cancers, yet millions of eligible Americans do not get screened as directed by guidelines,” said Vince Wong, Chief Commercial Officer at Geneoscopy. “Working with Labcorp, an organization trusted daily by thousands of clinicians and millions of patients, is an incredible opportunity to expand patient and clinician access to our noninvasive screening test. Given Labcorp’s extensive access to communities across the country, we believe this collaboration will help reduce the barriers to screening and address health inequities.”
Although colorectal cancer ranks second in U.S. cancer-related deaths overall and is the leading cause of cancer death in men younger than 50, research indicates a large proportion of colorectal cancer incidence and mortality is preventable through regular screening, surveillance, and high-quality treatment. Adding to this challenge, colorectal cancer incidence trends are rapidly shifting the patient population to younger individuals; 20% (1 in 5) of colorectal cancers in 2019 were in people 54 years or younger, up from 11% (1 in 10) in 1995, and over the past decade, incidence has increased for advanced disease, especially in people younger than 65 years of age. Geneoscopy’s technology offers this age group convenient at-home test collection with the highest sensitivity currently available for non-invasive CRC screening.
“This agreement builds on Labcorp’s commitment to bring the latest advancements in cancer screening and diagnostic testing to healthcare providers and patients,” said Dr. Brian Caveney, Chief Medical and Scientific Officer at Labcorp. “Geneoscopy’s highly sensitive colorectal cancer screening test, once approved, will be another innovative, accessible and reliable option available to providers and patients nationwide for the detection of colorectal cancer.”
Geneoscopy’s multi-target stool RNA (mt-sRNA) biomarker panel is designed to detect precancerous lesions and colorectal cancer. The company has submitted a Premarket Approval Application (PMA) to the FDA based on the favorable results from the pivotal CRC-PREVENT trial, in which Geneoscopy’s test demonstrated high sensitivity for CRC and advanced adenomas. Notably, for younger participants (ages 45 to 49), sensitivity for CRC was 100%. These results are the highest reported for any noninvasive CRC screening test in any prospective registrational clinical study completed to date.v