Tag: pneumonia diagnostics
Company News: Curetis AG and Cempra, Inc. Collaborate on the Detection of Community-Acquired Bacterial Pneumonia Pathogens
– Cempra to use Curetis’ Unyvero™ solution in its Phase III trial of its antibiotic solithromycin (CEM-101) –
Curetis AG and Cempra Inc. (NASDAQ: CEMP) today announced a research and development collaboration to incorporate Curetis’ Unyvero™ molecular diagnostic system into Cempra’s upcoming global Phase 3 trial of the oral formulation of solithromycin in patients with community-acquired bacterial pneumonia (CABP).
Under the terms of the agreement, each party may use the generated data for its own product development and for its regulatory filings.
Cempra’s randomized, double-blind Phase 3 trial comparing solithromycin against a comparator drug is expected to enroll over 800 patients in more than 100 clinical sites worldwide. Sputum samples from patients will be sent to Curetis for analysis with its Unyvero™ Solution and the CE-marked Unyvero™ P50 Pneumonia Application Cartridge. Molecular diagnostic data generated from the Unyvero™ Solution will be paired with clinical and traditional microbiology data to enhance the pathogen diagnosis rate in the trial. The trial is expected to start during the fourth quarter of 2012 and enrollment is expected to be completed in 2014.
Company News: Curetis AG Signs Distribution Deal in Middle East with ATC
– Kuwait Ministry of Health clears Unyvero™ Solution for clinical evaluation –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that it has signed an exclusive distribution deal for its Unyvero™ solution with Advanced Technology Company K.S.C. (ATC). ATC will become the exclusive distributor of the Unyvero Solution including consumables for the six Gulf Cooperation Council (GCC) countries and the Lebanon.
Placement of instruments will start in the third quarter this year. A clinical evaluation project of the Unyvero™ Solution has been approved by the Kuwait Ministry of Health and will take place at leading clinical sites in the country. Curetis, ATC and the clinical investigators will cooperate closely during this phase, and are planning to publish evaluation data in 2013 at a renowned international medical conference.
Company News: Curetis AG Achieves CE-Marking for Unyvero™ Solution and Initiates Commercialization
– Successful completion of performance evaluation study; CE Mark for Unyvero™ instrument system and pneumonia application –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments and the P50 Pneumonia Cartridge and that is has already initiated national and international commercialization activities. The performance evaluation of Curetis´ Unyvero™ System and the Unyvero™ P50 Pneumonia cartridge was successfully completed just recently.
The evaluation has demonstrated excellent performance characteristics of the Unyvero™ pneumonia application in terms of sensitivity and specificity. Overall sensitivity in 186 tested fresh and frozen clinical sputum, aspirate and lavage samples was above 75% sensitivity with a better than 95% specificity. The Unyvero™ P50 pneumonia application cartridge identified 74 additional pathogens missed by standard microbiology culture, which was used as gold-standard comparator in terms of performance. If confirmed with independent methods this might demonstrate that the Unyvero™ pneumonia test offers significant improvements in terms of sensitivity over current clinical standards. This analysis is ongoing.
Cartridge and instrument system have also passed other important criteria, such as repeatability, reproducibility, interference testing, and cross-reactivity. The complete performance evaluation study included 318 Unyvero™ P50 cartridge runs between January and April 2012.
Based on positive feedback from many potential distribution partners during the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) earlier this year, Curetis has also begun establishing its international distributor network and expects to target an even broader international market than originally anticipated beginning in 2012/13 already.
Company News: Curetis AG to Present Its Unyvero™ System for Pneumonia Diagnostics
– Demonstration supported by symposium on bacterial pneumonia and emerging antibiotic resistance at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the presentation of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge during the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in London.
The showcasing will be accompanied by the Curetis-sponsored Integrated Symposium “Bacterial Pneumonia and Emerging Antibiotic Resistance”, which will focus on pneumonia-causing pathogens, their respective antibiotic resistances, and the relevance of multiplexed molecular diagnostic testing. The event will be chaired by clinical microbiologist and molecular diagnostics specialist Prof. Christine Ginocchio (North Shore-LIJ Health System School of Medicine, New York), and Prof. Keith Klugman (Emory University, Atlanta), the world’s premier expert on antibiotic resistance among pneumococcal bacteria.
The Unyvero™ System is a versatile hardware platform for the detection of a broad panel of bacteria 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 report. The Unyvero™ P50 Cartridge is the first cartridge developed by Curetis AG and focuses on pathogen as well as antibiotic resistance testing for pneumonia. Each cartridge handles one patient sample and simultaneously analyzes 39 DNA targets. Results are available within less than 4 hours.