Tag: FDA trial
Company News: Mayo Clinic’s Dr. Robin Patel Named Principal Investigator for Curetis’ Unyvero™ LRT Trial
– Curetis adds six new trial sites, significantly expanding U.S. clinical trial network for ongoing FDA study
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.
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.
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.)