Tag: Robin Patel

Company News: Curetis Initiates Next Phase of Unyvero U.S. FDA Trial in Lower Respiratory Tract Infections

– First patient enrolled in prospective arm of IVD trial

– Study to include a total of at least 2,500 patient samples

– Milestone triggers payment of EUR 6.8 million financing tranche

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the enrollment of the first patient in the prospective phase of its Unyvero U.S. FDA trial.

The primary endpoint of the multicenter U.S. study will be the performance of Curetis’ second generation Unyvero Lower Respiratory Tract (LRT) cartridge, LRT55, in detecting lower respiratory tract infections as compared to microbiology culture – which is currently considered the diagnostic standard of care. In addition, Unyvero results will be compared to an independent molecular composite comparator based on pathogen DNA analysis by PCR and sequencing. At least eight trial sites across the U.S. will participate in the at least 2,500-patient study.

The new trial phase is based on an augmented study design and an enhanced product. This phase of the U.S. trial incorporates two new elements: the latest FDA guidelines for diagnostic trials, and modifications resulting from outcomes of the first phase of this trial. Enrollment completion is anticipated in mid-2016 with FDA submission targeted for the second half of 2016. The Company aims for FDA clearance for Unyvero and subsequent commercialization in early 2017.

The continuation of the trial triggers a EUR 6.8 million financing tranche supported by current Curetis investors.

LRT55 is a second-generation cartridge based on the design of the CE-IVD marked P55 cartridge marketed outside the U.S. It features 40 markers and a novel control concept with live bacteria in the control material and improved representation of pathogens in the panels. As a result, it provides the most comprehensive molecular marker panel for LRT infections marketed today. P55 has demonstrated superior performance in the CE performance evaluation study and additional investigator-initiated clinical studies.

In the U.S. FDA trial, tracheal aspirates and bronchial lavages will be pre-processed by the Unyvero Lysator and transferred to the Unyvero LRT55 cartridge, which is subsequently analyzed by the Unyvero Analyzer. Results are available within four-to-five hours.

The prospective arm of this trial includes at least 1,500 hospitalized patients with suspected lower respiratory tract infections to determine the clinical specificity of the Unyvero LRT55 cartridge.

In another arm of the study, at least 1,000 retrospective blinded patient samples will be analyzed for clinical sensitivity endpoints. All pathogens and resistance markers featured on the Unyvero LRT55 Cartridge will be included in the study. Already, Curetis has collected more than 500 retrospective patient samples across its clinical trial network. All retrospective samples have been tested positive for pathogens on the LRT55 panel by standard microbiology culture.

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.)