Genfit has developed a non-invasive test for non-alcoholic steatohepatitis (NASH) using its blood-based biomarker test.
Covance, the drug development business of LabCorp, will validate the test’s use for identification and characterization of patients, and to generate biological insights on the pathogenesis of NASH.
NIS4, Genfit’s test, used samples from 687 patients from two different cohorts to discover and internally validate the test, a spokesperson from Genfit told us. Through the agreement, the companies may be positioned to expand access of NIS4 to clinical research.
Currently, there are no extensively validated non-invasive diagnostic tests for NASH that address the evolving disease and therapeutic implications.
Through the partnership, LabCorp will distribute the test to clinical research facilities. Genfit will aim to release the test as a laboratory developed test (LDT) as early as 2019 for clinical research.
The Genfit spokesperson told us the goal of the partnership is “to provide an approved solution for routine clinical care that could be performed by any specialist.”
Genfit said it aims to submit a diagnostic test package for regulatory approval by 2020 in the US and Europe.
“Our ambition at this stage is much broader, with a solution designed to help all NASH patients, including those who will be identified as not needing drug therapy,” the spokesperson explained. “So not only will the diagnostic kit potentially improve the patient journey, help providers in identifying and managing patients, but we believe it will also allow researchers to collect essential data on NASH, and hopefully improve the understanding of its complex mechanisms.”
Financial terms for the agreement were not disclosed