- Curetis adds six new trial sites, significantly expanding U.S. clinical trial network for ongoing FDA study
Holzgerlingen, Germany, May 14, 2014 -- Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Robin Patel, M.D., Professor of Medicine and Microbiology at the Mayo Clinic in Rochester, Minn., has been named Lead Principal Investigator of the company’s Unyvero™ LRT Application FDA trial. The lower respiratory tract (LRT) application is designed to detect 17 pathogens and 22 antibiotic resistance gene markers of clinical importance in patients with suspected LRT infections. The Company also announced the addition of six new clinical trial sites in the last few quarters, expanding its clinical trial network to nine high-profile testing sites.
Dr. Patel, who chairs the Division of Clinical Microbiology and Mayo Clinic’s Bacteriology Laboratory and directs the Infectious Diseases Research Laboratory, is a specialist in the clinical detection and identification of bacteria, including the characterization of their antimicrobial resistance and susceptibility, particularly for biofilm-mediated infections. She succeeds Prof. Christine Ginocchio, M.D., formerly of North Shore-LIJ Health System Laboratories, who recently left North Shore-LIJ to assume a corporate position in the microbiology field.
“We are thrilled that Dr. Patel, a renowned physician heading one of the largest microbiology departments in the U.S. – and already an important part of this trial as Principal Investigator at Mayo Clinic for the last six months – has agreed to take on an expanded role as Lead Principal Investigator,” said Anne Thews, M.D., Medical Director of Curetis AG. “Robin is adept at relating her leading antimicrobial resistance and susceptibility expertise across indications, from respiratory tract to prosthetic joint infections. Because of this fluency in the resistance space, we believe this appointment will set the stage for Robin’s support of additional U.S. trials using Curetis’ Unyvero solution.”
“I also wish to thank Dr. Christine Ginocchio, who has been instrumental in the design and launch of our Unyvero LRT trial,” Dr. Thews added.
“I am honored to follow Dr. Ginocchio as Lead Principal Investigator of this trial investigating the performance of a highly multiplexed panel targeting multiple bacteria and antibiotic resistance genes in lower respiratory tract samples,” said Dr. Patel. “This is a new approach in diagnosing severe infections and it addresses an unmet medical need.”
To bolster enrollment and to capture potential geographical differences in pathogen and antibiotic resistance gene distribution, Curetis has also expanded its clinical trial network from three to nine testing sites over the past couple of quarters.
“We are proud to have attracted prominent, highly experienced and committed trial centers,” said Oliver Schacht, Ph.D., CEO of Curetis AG. “With these new sites now active, we are confident that we can complete enrollment by the end of the year, positioning Curetis to submit an application for FDA approval of the Unyvero™ LRT application in 2015.”
Participating trial centers testing at least 2,000 prospective lower respiratory tract samples include:
- David Geffen School of Medicine at UCLA (Los Angeles, Calif.)
- Johns Hopkins University School of Medicine (Baltimore, Md.)
- Northwestern Memorial Hospital (Chicago, Ill.)
- Mayo Clinic (Rochester, Minn.)
- North Shore-LIJ Health System Laboratories (Lake Success, N.Y.)
- University of Rochester Medical Center (Rochester, N.Y.)
- Weis Research Center/Geisinger Health System (Danville, Penn.)
- University of Washington Medical Center (Seattle, Wash.)
- William Beaumont Hospital (Royal Oak, Mich.).
Disclaimer
CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on the Curetis Unyvero™ technology is currently available for sale in the United States of America or Canada. The analytical and clinical performance characteristics of any Curetis Unyvero™ product which may be sold at some future point in time in the U.S. have not yet been established.
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About the Unyvero™ System
The CE-marked Unyvero™ System is a versatile hardware platform for the detection of a broad panel of bacteria, fungi and antibiotic resistances from a single sample in one run. It processes a disposable cartridge providing the necessary reagents to complete the analysis from sample to result. It is marketed in Europe, Russia, the Middle East and various other non-European countries. In the U.S., Curetis is running a prospective multi-center clinical trial aimed at achieving FDA clearance registered under http://www.clinicaltrials.gov/ NCT01922024.
The platform enables the DNA-based testing of all clinically relevant samples in a fully automated, unsupervised analysis process requiring only few, quick manual preparation steps. The analysis thus can be performed with minimal operator time and without the need of skilled staff or special infrastructure.
Thereby, clinically relevant information is available within about four hours to support an informed therapy decision as early as possible.
The first CE-marked Unyvero™ Cartridge, Unyvero™ P50, focuses on pneumonia testing and simultaneously analyses 39 DNA targets. The second CE-marked application, the Unyvero™ i60 ITI cartridge for implant & tissue infections, is also commercially available in Europe. Cartridges for additional indications are in various stages of development and preparation.
About Curetis AG
Founded in 2007, Curetis AG is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost-effective products for diagnosing severe infectious diseases. The diagnostic solutions of Curetis AG enable rapid multi-parameter pathogen and antibiotic resistance detection in only a few hours, a process that today can take up to days or even weeks with other techniques.
To date, Curetis has raised total funds of over €49.1 million (~ USD 65 million). The company is based in Holzgerlingen near Stuttgart, Germany. Curetis has signed collaboration agreements with Heraeus Medical, Sanofi Pasteur and Cempra Inc. as well as several international distribution agreements covering more than 20 countries.