The study is progressing rapidly, in line with the roadmap, and all results are expected in the third quarter of 2020.
RENNES, FRANCE— October 9, 2019
DIAFIR, medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions today announced the initiation and recruitment of the first patients of the clinical study SIGNALS (Signature diaGnostic of Nash by infrAred Light Spectroscopy). Primary goal: to validate its blood-based test for NASH diagnostic in severely obese subjects, the most common chronic liver disorder in western countries.
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 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. The main objective of this multicentre study is to prospectively validate the test performance in 500 severe obese patients.
Pr Rodolphe Anty, M.D., Ph.D., Hepatologist at the Nice University Hospital, Principal Investigator, stated: “Diafir technology applied to NASH diagnosis was tested in a monocentric pilot study (Anty et al. JHEP Reports 2019 in press). In this study, the high negative predictive value of the test ruled out the diagnosis of NASH in severe or morbid obese patients who had a negative test. Validation and improvement of this concept will be sought in this new multicentre prospective clinical study. Another clinical study, in parallel, evaluates this technology in patients suspected of having a NASH and referred to a specialized hepatology consultation. Diafir technology could complement the arsenal of non-invasive liver assessment tools available to physicians managing these patients”.
Jerome Bernard, General Manager of DIAFIR, said : « We are delighted to initiate this European multicentre clinical study, which will validate our blood test for early detection of the risk of NASH in severely obese patients, a population particularly at risk, and thus improve their therapeutic management. If the results are positive, we will consider commercialization of the test in Europe and initiate a similar study in North America in early 2021.”
The SIGNALS (Signature diaGnostic of Nash by infrAred Light Spectroscopy, NCT03978247) study is a clinical study to validate the performance of the non-invasive blood test for NASH (non-alcoholic steato-hepatitis), based on medium-infraouge specterscopy, in patients with severe obesity candidates for bariatric surgery. A sample of blood will be taken upstream of the surgical procedure in the fasting subject. The patient’s metabolic footprint will be analyse on serum from spectral data measured no more than two hours after sampling. The spectrum obtained by the SPIDTM spectroscopy platform will be processed by algorithmic analysis in order to construct the diagnostic test. During surgery, a liver biopsy will be performed and the
sample will be centralized and analyzed by an expert who will determine the histological diagnosis of the tissue collected. The two results obtained by the spectroscopy test and through the biopsy will be compared to determine the diagnostic performance of the developed test.
A total of 500 patients will be included in the study at more than 10 sites in France and Belgium. Results are expected in the third quarter of 2020.
DIAFIR is a medical technology company specializing in the development of innovative in vitro diagnostic tests to improve the diagnosis and monitoring of patients with chronic metabolic diseases or infectious pathologies. Our technology is based on infrared analysis of patients’ metabolic fingerprint through our SPID TM platform, which enables low-invasive, cost-effective, and fast diagnostic procedures. DIAFIR aims to improve the management of care by bringing its simple serologic test to the front line to detect and monitor all potentially NASH patients. The NASH screening test is currently undergoing clinical studies, with an ambitious roadmap to obtain the regulatory approvals needed for commercialization in 2021.
Contact DIAFIR :Jerome Bernard, PhD
+33 (0)2 99 67 15 41 www.diafir.com