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Labcorp introduces novel, noninvasive diagnostic test for NASH, NASHnext in US & Canada

Lille, France
Tuesday, May 4, 2021, 17:00 Hrs  [IST]

GENFIT, a late-stage biopharmaceutical company, announced the launch of NASHnext, a novel, noninvasive diagnostic test for nonalcoholic steatohepatitis (NASH). The test is offered exclusively in the US and Canada through Labcorp, a leading global life sciences company.

NASHnext is powered by NIS4, GENFIT’s proprietary diagnostic technology that uses a novel, blood-based molecular biomarker test to identify NASH and significant fibrosis, also referred to as at-risk NASH, in patients with at least one metabolic risk factor, as published in The Lancet Gastroenterology and Hepatology.

NASH, the most severe form of nonalcoholic fatty liver disease (NAFLD), is a highly under diagnosed cause of severe liver complications. NAFLD, a precursor to NASH, is estimated to affect nearly 80 million people in the US, but only 5 percent of patients are aware of their liver disease due to its asymptomatic nature and limited availability of tests, with highly invasive liver biopsy being the current clinical standard to diagnose it. Individuals meeting appropriate clinical criteria to support suspected cases of NAFLD or NASH are target populations for NASHnext testing, one of the first blood-based tests that provides a simple score for the diagnosis of both NASH and significant to advanced liver fibrosis.

“Labcorp supported the research and development of NASHnext through our drug development business, and now through our diagnostics capabilities, we can bring this valuable experience and the test to millions of patients. NASH is a widespread yet under diagnosed liver disease with very serious consequences including end-stage liver disease and cardiovascular events,” said Brian Caveney, M.D., chief medical officer and president of Labcorp Diagnostics. “NASHnext has the potential to substantially benefit very large patient populations by providing people with essential information regarding their liver health. With a clear diagnosis and the help of their doctors, patients will be able to make informed decisions and implement strategies to monitor or slow the progression of their liver disease.”

In September 2020, GENFIT entered into a licensing agreement with Labcorp for the development and commercialization of a blood-based molecular diagnostic test powered by GENFIT’s NIS4 technology. Since early 2019, Labcorp Drug Development has been offering the test to global researchers, which has also provided Labcorp with valuable experience in the validation and performance of the test. With the clinical launch of NASHnext, healthcare providers and patients across the US and Canada now have convenient access to this powerful new tool that provides vital information about a serious health condition that is under diagnosed.

“The commercialization of NASHnext by Labcorp is a major milestone for the entire NASH field. We believe that the capabilities and reach of Labcorp, a highly regarded life sciences company, will allow for wide and early availability of the test to help both patients and healthcare professionals manage NASH at scale,” said SuneilHosmane, global head of diagnostics at GENFIT.


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