Tag: in vitro diagnostics (IVD)
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.)
Company News: Curetis Launches Unyvero™ i60 Implant and Tissue Infection Cartridge in Europe
– Successful completion of CE performance evaluation study covering more than 400 patient samples
– Sales and Marketing Program Underway in Germany, Austria and Switzerland
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has launched its new Unyvero™ i60 Implant and Tissue Infection (ITI) cartridge in Europe. The new cartridge for the Unyvero™ system was developed to rapidly identify more than 90 pathogens and more than 20 resistance markers common in eight clinical indications. Commercial launch and roll-out has already begun in close collaboration with Heraeus Medical GmbH, the development and commercialization partner for the Unyvero™ i60 cartridge. The Company has made first placements at major clinical centers in Germany, Austria and Switzerland (DACH market).
The i60 cartridge has been CE-IVD marked following the successful completion of a CE performance evaluation study involving more than 750 cartridges. Analytical sensitivity testing was conducted in 350 cartridges, while more than 400 cartridges were run with patient samples. Samples of various clinical indications were obtained for the trial, including periprosthetic joint infections, diabetic foot, catheters, surgical sites, skin and soft tissue and cardiology-related infections. The Unyvero™ system analyzed challenging native clinical sample types such as swabs, synovial fluid, sonication fluid, tissue and catheters. Among others, the i60 cartridge detected several key pathogens with sensitivities in the range between 75% to 100% at an overall panel sensitivity of 67% and panel specificity of 97.8% for the 81 analytes that have been successfully validated so far. The i60 cartridge also identified 147 clinically important pathogens not found by standard microbiology culture. In particular, in every second sonication fluid and every third synovial fluid sample, i60 detected pathogens missed by microbiology culture. Pathogens most often overlooked by culture, yet identified by i60, were Enterococcus sp., Finegoldia magna, Corynebacterium sp., Enterobacter cloacae, and Acinetobacter baumannii. Resolution of these discrepant results is ongoing.
Curetis and its distribution partners will introduce the Unyvero™ i60 ITI cartridge at the 2014 ECCMID conference in Barcelona, Spain (9-13 May 2014 – Booth 39), where the Company will also host the Medical Symposium, ”Implant and Tissue Infections – Challenges and Opportunities“ (May 10, 2014, from 13:30 – 15:30 in Hall J).
Company News: Curetis Obtains Key Patent for Unyvero™ Technology
– Australian patent office grants patent for integrated amplification and detection in Unyvero™ cartridges
– Patent covers unique combination of end-point PCR with array-based detection
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has been granted a core technology patent by IP Australia, the Australian patent office, for its Unyvero™ platform technology. The patent, “Reaction Vessel For PCR Device and Method of Performing PCR,” is the first of several core technology patents filed by Curetis. Its claims cover PCR chamber vessels allowing the integrated amplification and detection of DNA sequences. Curetis has submitted patent applications covering this technology in other key regions, including Europe, the U.S. and Japan. The Company expects these additional patents to be granted in the near future.
Further patents covering additional aspects of the Unyvero™ Solution, e.g. the unique sample lysis technology, are pending.
Company News: Curetis and Laboratorios LETI Sign Exclusive Distribution Agreement for Unyvero™ in Spain and Portugal
– Five-year agreement based on extensive health economic assessment –
Curetis AG today announced that the company has closed an exclusive distribution agreement in Spain and Portugal with Laboratorios LETI, which includes all existing and future Unyvero™ instruments and consumables. LETI is a biopharmaceutical company based in Tres Cantos, near Madrid, Spain. Its diagnostics business unit distributes and markets a broad portfolio of in vitro diagnostics (IVD) and research products, among other offerings.
The agreement, effective January 1, 2014, was finalized following positive market feedback and favorable outcome of a joint, extensive health economic assessment which included four major hospitals in Spain and Portugal. The commercial launch of Unyvero™ in this region is expected in the first quarter of 2014.
For the implementation, Curetis will provide Unyvero training, marketing materials and supporting health economic research. LETI will manage all marketing and sales activities as well as storage and logistics support. The partners are targeting a market share of more than 50 percent of relevant hospitals and ICU units in the region within the next five years.