Category: Non classé

Synofresh is a study performed from 2019 to 2021 within 6 French hospital (Rennes, Angers, Brest, Clermont-Ferrand, Nantes, Tours) and included 385 patients affected by severe arthritis.
Performance of SYNOFAST score is consistent with initial findings on Synofast et DeFrost cohorts (https://doi.org/10.1093/rheumatology/keaa373), i.e. exclude non infected patients with a high level of confidence within 15 minutes.
It helps securing the clinician decision, and the study shows that a non infected SYNOFAST score leads to lesser hospital stay and faster corthicotherapy treatment for a better patient care.

Loïc Maurel is Medical Doctor and cumulates 30 years of senior management experience in tier-one pharmaceutical, biotech and Diagnostics companies.

As the CEO of the Diaxonhit Group (now Eurobio Scientific), Loïc inspired and led the transformation of a pure biotech company, into a full fledge commercial IVD company, following the acquisition of Ingen BioSciences and Eurobio.

He occupied several positions as, CEO of Debiovision Inc., Vice President , Marketing & Specialty Business at Novartis Canada after moving from Basel, Switzerland where he headed Global Marketing for Cardiovascular/Metabolism & Respiratory Therapeutic Division at Novartis Headquarters.

Dr. Maurel occupied several Chairman or Board member’s positions at, OncoMab™ GmbH, Avance Pharma and Trans Hit Biomarkers, the BioQuebec association, in Canada, as well as France Biotech, the IVD Medicen DAS, the Diagnostics Advisory Board of Debiopharm SA in Switzerland and the Health Expert Committee of M Capital in Paris

RENNES, FRANCE— November 04, 2020

DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions, today announced that an abstract has been selected for poster presentation during the upcoming The Liver Meeting Digital Experience™ 2020, organized by the American Association for the Study of Liver Disease (AASLD) on November 13-16, 2020.

The abstract covers new data, in collaboration with University Hospital of Nice, France, evaluating the diagnostic performance of Diafir’s NASH blood-based test, focusing in type-2 diabetic (TD2M) severely obese patients.

The details of the presentation are as follow:

Abstract title:              “Mid-Infrared spectroscopy blood-based test correctly identifies NASH risk in severely obese patients with type 2 diabetes”

Publication number: 1529

Session title:                Poster, Category Index NAFLD and NASH, Diagnostics and Biomarkers

Presentation type:     Poster presentation

Author:                          Prof. Rodolphe Anty, University Hospital Nice, France.

The abstract is featured in the November issue of the scientific journal Hepatology (vol. 72, issue S1) and is available on the website of AASLD (www.tlmdx.aasld.org)

ABOUT AASLD

AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD fosters research that leads to improved treatment options for millions of liver disease patients. We advance the science and practice of hepatology through educational conferences, training programs, professional publications, and partnerships with government agencies and sister societies.

ABOUT DIAFIR

DIAFIR is a medical technology company with expertise in developing disruptive in vitro diagnostic tests to improve the patient care management. Our technology relies on spectroscopic 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 is an ISO 13485 company.

Contact DIAFIR :                                                 

Jerome Bernard                       

General Manager Healthcare                                       

info@diafir.com                                                               

+33 (0)2 99 67 15 41                                          

www.diafir.com

Jean-David Albert, Maëna Le Corvec, Olivia Berthoud, Claire David, Xavier Guennoc, Emmanuel Hoppe, Sandrine Jousse-Joulin, Benoît Le Goff, Hugues Tariel, Olivier Sire…

The aim of this study was to show the usefulness of a mid-infrared fibre evanescent wave spectroscopy point of care device in the identification of septic arthritis patients in a multicentre cohort, and to apply this technology to clinical practice among physicians.

https://doi.org/10.1093/rheumatology/keaa373

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.”

ABOUT SIGNALS
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.

ABOUT DIAFIR
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
General Manager

info@diafir.com
+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.”

ABOUT DIAFIR

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, info@diafir.com, +33 (0)2 99 67 15 41

Contact CHU ANGERS :
Audrey Capitaine,  Press Relation, audrey.capitaine@chu-angers.fr, +33 (0)2 41 35 79 97
 www.chu-angers.fr

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 SPID^TM 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».

 

Press release