Archive: Company News
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: New Favorable Clinical Evaluation Data for Unyvero™ P50 Pneumonia Application
– Dutch study demonstrates excellent sensitivity of Unyvero™ cartridges –
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced positive clinical data from an independent study conducted by researchers from the Department of Medical Microbiology of Maastricht University Medical Center (MUMC), Maastricht, the Netherlands. The data demonstrate the high clinical sensitivity of the Unyvero™ P50 Pneumonia application in detecting pathogens, including samples with low pathogen concentrations.
The researchers compared the performance of the Unyvero™ P50 cartridge with conventional microbiology culture in broncho-alveolar lavage fluid (BALF) samples for the diagnosis of ventilator-associated pneumonia (VAP), a common complication in intensive care patients. The most frequent causes are Pseudomonas aeruginosa, Staphylococcus aureus and Enterobacteriaceae.
Using the quantitative culture standard, Unyvero™ P50 Pneumonia correctly detected 8 different important pathogens in all VAP samples (n=44) at 100% sensitivity. The overall sensitivity of the Unyvero™ P50 panel was 88.6% at clinically relevant pathogen concentration. Unyvero™ P50 was also able to detect 8 different clinically relevant pathogens in 12 patient samples where conventional microbiology culture failed. This data confirms previous results where Unyvero™ had consistently detected pathogens missed by conventional culture.
The data were presented at the Scientific Spring Meeting of the Koninklijke Nederlandse Vereniging voor Microbiologie (Royal Dutch Society for Microbiology) KNVM and Nederlandse Vereniging voor Medische Milieukunde (Dutch Association for Environmental Medicine) NVMM 2014 in Arnhem, The Netherlands.
Company News: Anergis Completes Enrolment in the Long-Term Efficacy Trial of Lead Compound AllerT
– Results expected for Q3, 2014 –
Anergis, a company discovering and developing proprietary allergy vaccines, today announced that it has completed the enrolment of 196 subjects in the long-term efficacy trial of its birch pollen allergy vaccine AllerT, and expects to release results in the third quarter of 2014.
The long-term efficacy trial of AllerT is a double-blind, placebo-controlled, field-based clinical trial assessing the persistence of the efficacy of AllerT in post-treatment years.
All 196 patients participated in the field-based Phase IIb trial with AllerT in 2013. They all received a two-month double-blind, randomized treatment with AllerT or a placebo prior to the 2013 birch pollen season, and were then followed for efficacy during the 2013 birch pollen season, i.e. in conditions of natural pollen exposure. Last year’s Phase IIb trial had shown the efficacy of AllerT on allergy symptoms during the first post-treatment birch pollen season, based on combined symptom and medication scores, quality of life and other endpoints.
In the new long-term efficacy trial, the enrolled patients agreed to collect their daily allergy symptoms and allergy medication using electronic diaries, exactly as was done during the previous trial/season. The patients have not received any further investigational treatment since their pre-seasonal two-month treatment in early 2013.
The trial will thus provide efficacy data for AllerT during the second season post-treatment without any intervention since the initial two-month, pre-seasonal treatment. Anergis had already shown that patients from the AllerT Phase IIa trial had a persistent elevation in allergen-specific antibodies (IgG4) until at least the fourth post-treatment season.