GENFIT, a biopharmaceutical company committed to improving the lives of patients suffering from liver and metabolic diseases, and LabCorp®, a leading life sciences enterprise focuses on guiding patient care decisions and improving health, have signed a five-year exclusive licensing contract for GENFIT’s NIS4™ technology to help in identifying the patients with at-risk non-alcoholic steatohepatitis (NASH). According to the deal, the life sciences company will develop and advertise a blood-based molecular diagnostic test that will be powered by NIS4™ technology throughout Canada and the US, allowing widespread access to healthcare providers.

Due to the limitations of present diagnostic approaches and its asymptomatic nature, NASH remains an extremely underdiagnosed disease. Liver biopsy, which is a highly invasive procedure, is the existing clinical standard to officially diagnose NASH and to control the phase of fibrosis. NIS4™ technology is a new multi-biomarker-based algorithm explicitly built to recognize at-risk NASH, defined as the existence of NASH based on a non-alcoholic fatty liver disease activity score and important to advanced fibrosis.

Patients suffering from at-risk NASH have a progressive form of the disease and face a higher likelihood of advancements to severe complications, including cirrhosis, liver cancer, and the requirement for a liver transplant if it is left untreated. One test score generated from the deployment of four independent biomarkers, including alpha-2-macroglobulin, HbA1c, miR-34a-5p, and YKL-40, can be utilized by the healthcare providers to inform the best course of involvement.

This contract with LabCorp will offer extensive clinical availability of the test to primary and specialty care physicians across Canada and the US. The organization will leverage its deep experience in commercializing advanced diagnostics to enlighten providers about NASH and the importance of non-invasive testing. The partnership between the two companies began in 2019 when LabCorp started offering NIS4™ technology to biopharmaceutical customers for use in clinical studies via Covance, LabCorp’s drug development business.

Source: https://www.globenewswire.com/news-release/2020/09/28/2099662/0/en/GENFIT-and-LabCorp-Sign-Exclusive-Agreement-to-Commercialize-a-Novel-Diagnostic-Test-for-Liver-Disease.html