Geneoscopy and Labcorp have signed a multi-year agreement for the distribution of the noninvasive multi-target stool RNA (mt-sRNA) colorectal cancer screening test.
The deal will accelerate the availability of Geneoscopy’s next-generation colorectal cancer screening test, which provides at-home collection and high sensitivity for early identification of cancer.
Geneoscopy’s mt-sRNA biomarker panel is intended for identifying colorectal cancer and precancerous lesions.
The test is being reviewed by the US Food and Drug Administration (FDA) under the premarket approval application (PMA).
The company submitted the PMA based on positive data from the pivotal CRC-PREVENT study, which showed high sensitivity of the test for CRC and advanced adenomas.
In this trial, sensitivity for CRC was found to be 100% in younger participants aged between 45 and 49 years.
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Geneoscopy chief commercial officer Vince Wong said: “Working with Labcorp, an organisation 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.”
Upon FDA approval, Labcorp will provide the test, to be conducted by Geneoscopy, allowing healthcare customers to easily order it through the former as part of their screening programmes.
Labcorp chief medical and scientific officer Dr Brian Caveney said: “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.”