French biopharmaceutical company GENFIT has signed a five-year exclusive licensing agreement with US-based LabCorp for the development of a novel diagnostic test for liver disease.

As part of the agreement, LabCorp will develop a blood-based molecular diagnostic test, using GENFIT’s NIS4 technology to help identify patients with at-risk non-alcoholic steatohepatitis (NASH).

Additionally, LabCorp will commercialise the test across the US and Canada.

NASH, which is asymptomatic in nature, is considered to be a highly underdiagnosed disease. Liver biopsy, a highly invasive procedure, is the existing clinical standard for the diagnosis of this condition.

If left untreated, the condition may advance into severe complications, including liver cancer, cirrhosis and the need for a liver transplant.

A single test score generated from the integration of four independent biomarkers – miR-34a-5p, alpha-2-macroglobulin, YKL-40, and HbA1c – can be used by a healthcare provider to help inform the best course of the intervention.

LabCorp Diagnostics chief scientific officer Marcia Eisenberg said: “LabCorp is committed to developing and distributing novel diagnostics to support the diagnosis of patients with NASH, which is one of the fastest-growing serious medical conditions in the US.

“GENFIT’s NIS4 is a non-invasive technology specifically designed to identify patients with both NASH and significant to advanced fibrosis and is an important advance in the ability to identify patients with NASH. We have gained valuable experience with this test since we began performing it in 2019 for clinical studies with biopharmaceutical clients, which will provide insights as we develop and prepare to make it available for use in patient care.”

LabCorp will use its expertise in commercialising diagnostics to educate health providers on NASH and the importance of non-invasive testing.

GENFIT Global Diagnostics head Suneil Hosmane said: “We are pleased to expand our collaboration with LabCorp and are very enthusiastic about the potential impact of this agreement.

“We strongly believe that this test will help healthcare providers identify the approximately ten million patients with at-risk NASH and a higher risk of progression among the tens of millions with metabolic risk factors, such as type 2 diabetes and obesity, and suspected disease.”

Last year, GENFIT and LabCorp partnered to offer NIS4 technology to biopharmaceutical clients for use in clinical studies through LabCorp’s drug development business Covance.