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
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
RENNES, FRANCE — March, 29 2019 — DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions in nonalcoholic steatohepatitis (NASH) and septic arthritis announces today the appointment of Mr Richard Guillaume to its Board of Directors
Mr Guillaume has a wide experience of over 30 years in international management and operations in the pharmaceutical industry as well as in the medtech. Drawing on his experience and knowledge in the field of medical devices and diagnosis, Mr Guillaume will advise and help the Company in its development.
Alongside his role at Diafir, Richard Guillaume has been the General Manager of Echosens from 2008 until 2013. He was previously Executive Vice President Global Sales and Marketing at Blatchford, a UK medical device company. He was also member of the board. Prior, he held various positions such as Director Global Marketing of Abbott International in Chicago and Director Category Development Europe of Mead Johnson. Richard holds a Master in Business Administration from Poitiers University and a DESS in Marketing from Paris Dauphine completed by a general management program at INSEAD.
Hugues Tariel, Founder and CEO of DIAFIR, said: “We are delighted to welcome Richard as a Diafir board member. His vision and experience will be a great addition to our team, to ensure SPIDTM platform success for NASH in hepatology and more broadly as an accurate, fast and versatile diagnostic tool.” Richard Guillaume, declared: “I’m pleased to join the board of Diafir who is developing a new innovative in vitro diagnostic technology to improve patient quality of life».
DIAFIR will be in Vienna from April 10-14, 2019 for the annual EASL International Liver Disease Conference.
EASL (European Association for the Study of the Liver) is a medical association dedicated to the pursuit of excellence in the field of liver research, the clinical practice of liver disorders and training.
Its goal is to spread knowledge and expertise on best practices and the latest scientific breakthroughs in hepatology.
This year Diafir will still travel a lot. Our next dates of congress and participation in scientific events.
- 10-14 Avril 2019 : EASL, Vienne, Autriche
- 14-16 Mai 2019 : MedTech Europe, Paris, France
- 5-7 Juin 2019 : National Infectiology Day, Lyon, France
- 12-15 Juin 2019 : EULAR, Madrid, Espagne
- 11-12 Juillet 2019 : NASH Symposium, Paris, France
- 8-12 Novembre 2019 : AASLD, Boston, USA
- 21-22 Novembre 2019 :Innovation Day in Biology,, Paris, France
- 8-10 Décembre 2019 : Congress French Society of Rheumatology, Paris, France
These events are opportunities to meet, do not hesitate to contact us before. Contact form
The fourth event of the Photonic Roadshow was held in Marseille on November 17th. It is an understatement that the meetings
were rich. Experts from all countries covered a wide range of topics ranging from medical market trends and needs to photonic technologies, to the transformation of regulatory requirements into value added for products.
We presented the DIAFIR journey and developed the topic of health by focusing on the essential aspect of the regulatory qualification of a photonic equipment for the medical.
Thank you again for your enthusiasm.
(thanks to Laëtitia Clavé from the OPTITEC Pole for the photo)
DIAFIR will be present from 3 to 6 October in Lyon at the scientific days of the AFEF (French Society for the Study of the Liver).