– U.S. FDA trial enrolment on track –
Curetis N.V., a developer of next-level molecular diagnostic solutions for syndromic infectious disease testing, today announced the establishment of its Medical Advisory Board (MAB). Initially, it will consist of four leading experts in their respective fields: Dr. Reno Frei (former Head of the Division of Clinical Microbiology, University Hospital Basel, Switzerland), Prof. Mathias Pletz, MD (Jena University Hospital, Germany), Prof. Jean-Louis Vincent, MD, PhD (Hôpital Universitaire Erasme, Brussels/Belgium), and Prof. Robin Patel, MD (Mayo Clinic, USA), who also serves as Principal Investigator of Curetis’ ongoing U.S. FDA trial.
The newly established MAB is expected to meet several times per year and chair roundtables with further key opinion leaders in the field to advise the company on important trends and issues in clinical microbiology as well as novel product concepts addressing high medical need questions in the diagnosis of severe infections in hospitalized patients. The company expects the MAB to provide valuable insight and guidance along the entire value chain of innovative molecular diagnostics products including concept, definition, clinical validation, and positioning.
“We are very proud to have won these outstanding, seasoned experts for our Medical Advisory Board,” said Dr. Anne Thews, Medical Director of Curetis. “They combine tremendous experience in the areas of severe infectious diseases including sepsis and prosthetic joint infections, in critical care, clinical microbiology, and further relevant areas. All of them have been working with Curetis over the past couple of years in various roles and functions, in particular in clinical evaluations and studies for our Unyvero product line, such as the ongoing U.S. study to support product clearance for our LRT55 lower respiratory tract application by the FDA.”
She explained further that by bringing together these key opinion leaders in a dedicated medical advisory board, the company expects to synergistically leverage the complementary expertise and experience represented in the board.
On the progress of the Unyvero LRT55 U.S. study, Dr. Thews added: “The trial is progressing well and on schedule with more than 900 patient samples already enrolled and tested with Unyvero.”
Prof. Jean-Louis Vincent of Brussels’s Hôpital Universitaire Erasme commented: “As rising antibiotic resistance has become an enormous threat for modern medicine, we as critical care clinicians demand faster pathogen identification and resistance detection in order to optimize our treatment for each patient. Modern, patient-near molecular testing solutions like the Unyvero System have the potential to significantly improve patient care. Therefore, I am pleased to contribute my thirty years of experience in this field to help further expand the Unyvero Solution.”
Biographical sketches and achievements of Curetis’ Medical Advisors are as follows:
Reno Frei, MD, was Head of the Division of Clinical Microbiology, University Hospital Basel, Switzerland, for more than 25 years. His research focuses on antibiotic resistance, microbiological diagnostics, and healthcare-associated infections including prosthetic device infections and sepsis. He has published 250 peer-reviewed articles and book chapters. Dr. Frei received his medical degree from the University of Basel Faculty of Medicine in 1980. He completed his training in infectious diseases and laboratory medicine with a research fellowship at the University of Iowa College of Medicine, Iowa City, USA.
Mathias Pletz, MD, Professor of Infectious Diseases, is Director of the Center for Infectious Diseases and Infection Control at the Jena University Hospital, Germany. Prior to that, he worked at the Department for Respiratory Medicine at Hannover Medical School (Hannover, Germany), the Respiratory Diseases Branch of the Center for Disease Control and Prevention (Atlanta, USA) and at the Chest Hospital Heckeshorn (Berlin, Germany). His research focuses on respiratory tract infections and strategies against difficult to treat bacterial infections. This includes rapid tests for antimicrobial resistance and novel approaches to eradicate biofilms. Dr. Pletz has received numerous grants and scientific awards, such as the Honor Award Certificate from the CDC, and has published more than 130 peer-reviewed publications.
Jean-Louis Vincent, MD, PhD, is Professor of Intensive Care at the University of Brussels and Intensivist in the Department of Intensive Care at the Erasme University Hospital in Brussels, Belgium. He has published more than 900 peer-reviewed articles, some 400 book chapters and review articles, 950 original abstracts, and has edited 101 books. Among others, he is the Editor-In-Chief of Critical Care, Current Opinion in Critical Care and ICU Management and a member of the editorial boards of about 30 other journals. Jean-Louis Vincent received numerous awards, including the prestigious Prix Scientifique Joseph Maisin – Sciences biomédicales cliniques. Prof. Vincent is a Past-President of the European Society of Intensive Care Medicine and presently President of the World Federation of Societies of Intensive and Critical Care Medicine.
Robin Patel, MD, Professor of Medicine and Professor of Microbiology, is Director of the Clinical Bacteriology Laboratory and the Infectious Diseases Research Laboratory and Chair of the Division of Clinical Microbiology, Mayo Clinic, USA. Prior to taking a staff position at Mayo in 1996, she completed residencies in Internal Medicine and Microbiology in Rochester, Minnesota, and a fellowship in Infectious Diseases at the College of Medicine, Mayo Clinic. Robin Patel’s research focuses on clinical bacteriology diagnostic testing, antimicrobial resistance, and microbial biofilms. She has published over 250 peer-reviewed manuscripts and has delivered numerous national and international presentations. She graduated from Princeton University with a BA in Chemistry in 1985 and from McGill University in Montreal, Canada, with an MD (C.M.) in 1989.