Today, clinicians rely on a liver biopsy to identify and diagnose non-alcoholic steatohepatitis (NASH). In order to improve the management of patients, the development of a non-invasive screening tool appears to be necessary. That is why DIAFIR and hepatologists at the CHU of Angers are working together to clinically validate a non-invasive NASH test, based on medium-infrared technology.
RENNES, FRANCE and ANGERS, FRANCE — July 1st 2019
DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions, and the hepatology-gastroenterology and digestive oncology department of the CHU of Angers, specializing in the research and development of non-invasive liver tests, announced today the signing of a collaborative clinical research agreement. Goal: to validate a non-invasive test for NASH, the most common chronic liver disorder in western countries.
5% of the adult population affected by NASH: The importance of a new screening method Non-alcoholic steatohepatitis (or NASH) is a possible consequence of metabolic disorders such as obesity or type 2 diabetes. It is estimated that more than 5% of the adult population in developed countries is affected by NASH. Its main consequences are cirrhosis and hepatocellular carcinoma. Today, a histological examination of the liver by biopsy is required to identify and diagnose NASH. The development of a new non-invasive method is therefore a need recognized by public health authorities and necessary to improve patient management.
From liver biopsy to a single drop of blood serum
To meet this urgent need, DIAFIR is developing a non-invasive NASH screening test: just a drop of serum is enough.This test is ultimately intended to replace the current invasive procedure. This patented technology combines the recording of the metabolic signature of blood serum by mid-infrared via the SPID™ platform and the delivery of a diagnostic score using a proprietary algorithm. This test was developed on the basis of several biobanks from NASH patients who had undergone a liver biopsy. The main objective of this collaboration is to make available the SPID™ platform within the hepatology department of the CHU of Angers and seven other Universit hospitals in France to prospectively assess up to 1,000 patients in two years.
“We are very pleased to announce this collaboration, which represents an important step in the development of DIAFIR in NASH research,” said Jérôme Bernard, General Manager of DIAFIR. “The expertise of the hepatology department of the CHU of Angers in the field of non-invasive diagnosis of NASH will bring a fundamental added value to the previous studies carried out by DIAFIR in the development of this innovative technology. I am pleased with this collaboration, which will allow the test to become an in vitro diagnostic tool (IVD) for NASH patient identification.”
Jerome Boursier, MD, Ph. D, hepatologist at the CHU of Angers stresses the importance of this joint clinical research project: “There is still no validated non-invasive tool for the diagnosis of NASH. In this context, DIAFIR brings an innovative device to the family of non-invasive liver tests. Their new spectroscopy technology can identify NASH-at-risk patient in less than an hour, positioning the SPID™ platform as a gateway to patient management in clinical practice.”
DIAFIR is a medical technology company with expertise in developing innovative in vitro diagnostic tests to improve the detection and monitoring of patients with chronic metabolic diseases and infectious diseases. Our technology relies on mid-infrared analysis of the metabolic signature of patients using our SPID ™ platform, which allows for low-invasive, cost-effective and rapid diagnostic procedures. DIAFIR aims to improve patient care management by bringing its simple serological test to the front line in order to detect and track all potential patients with NASH. The NASH screening test is currently being clinically tested, with an ambitious roadmap to obtain regulatory approvals for the commercialization by 2021.
ABOUT THE HEPATOLOGY CLINICAL UNIT OF UNIVERSITY HOSPITAL CENTER OF ANGERS
The Hepato-Gastroenterology department of the University Hospital center of Angers specializes in the development and validation (diagnosis, prognosis) of non-invasive liver tests. In collaboration with the departments of pathology, biochemistry and radiology, as well as the biological resources center of the University Hospital center of Angers, they draw on their long experience in chronic viral hepatitis to work in the field of NAFLD and propose solutions for the identification of patients with active disease who will benefit from new treatments currently being evaluated in clinical trials.
Contact DIAFIR :
Jerome Bernard,General Manager, firstname.lastname@example.org, +33 (0)2 99 67 15 41
Contact CHU ANGERS :
Audrey Capitaine, Press Relation, email@example.com, +33 (0)2 41 35 79 97