Tag: Unyvero™ P50 Pneumonia Cartridge

Company News: Curetis to Launch Next-Generation Pneumonia Application at ECCMID 2015

Company Successfully Completes Clinical CE Performance Evaluation of Unyvero P55 Pneumonia Application

Clinical sensitivity across 40-marker panel averages 94% at 99.4% specificity

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the successful completion of the clinical and analytical CE performance evaluation of its next-generation Unyvero P55 Pneumonia Application. The upgraded cartridge will launch at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID, April 25 – 28, 2015 in Copenhagen, Denmark) and is supported by more than 800 cartridge runs and over 400 patient samples.

Unyvero P55, which is replacing the current P50 cartridge, identified a total of 127 additional pathogens compared to microbiology culture. Discrepant results have been resolved by independent PCR and sequencing and validated 93 cases as true positives, e.g. cases where traditional microbiology culture missed the pathogen.

The Unyvero P55 Pneumonia Application demonstrates superiority over culture and key enhancements compared to the P50 cartridge, evidenced by pathogen and resistance expansions and improved sensitivity proven in the CE clinical performance study. Specific upgrades include:

  • Expansion to detect 21 pathogens, including new targets Mycoplasma pneumoniae, Citrobacter freundii, Enterobacter aerogenes and Klebsiella variicola
  • Addition of critical antibiotic resistance markers (now a total of 19), including genes coding for carbapenem (imp, ndm, vim, oxa-23, oxa-24, oxa-48, and oxa-58 markers) and oxacillin (mecC) resistance
  • Improvements to sensitivity for several analytes, i.e.
    • Greater than 90% for most pathogens on the P55 panel, including Pseudomonas aeruginosa
    • Greater than 92% for Staphylococcus aureus
    • Near 100% for Pneumocystis, E. coli and Moraxella catharralis.

Comprehensive data supporting the next-generation Pneumonia Application will be presented at ECCMID.

The European and international roll out (excluding North America) commences in April 2015. Pricing for the P55 Pneumonia Application remains unchanged from the P50 cartridge. In the U.S., the P55 is being used under the label LRT55 as a Lower Respiratory Tract (LRT) Application in a U.S. FDA clearance trial, which is expected to be completed in 2016.

Company News: Curetis Presents Product Updates at Intensive Care Conference

Multiple Unyvero product launches planned for 2015

Clinical trial aimed at US FDA clearance of Unyvero adapted to reflect most recent FDA guideline issued in Q3-2014

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the presentation of its product range at Germany’s biggest congress on intensive medicine and intensive care, Symposium Intensivmedizin + Intensivpflege, in Bremen from February 18-20, 2015. Curetis will be exhibiting the Unyvero Solution at booth #N27, hall 4 at Messe & Congress Centrum Bremen. Curetis is also providing an update on its pipeline of new products to be launched in 2015.

By the end of 2014, the installed base of Curetis´ Unyvero Solution has grown to more than 60 systems world-wide. Unyvero is a versatile hardware platform for the detection of a broad panel of bacteria, fungi and antibiotic resistances from a single sample in one run. At present, cartridges for pneumonia testing (Unyvero P50) and for implant & tissue infections (Unyvero i60 ITI) are available in Europe. The company is expecting the European launch of its enhanced and expanded Unyvero P55 Pneumonia application in the spring of 2015.

By mid 2015, Curetis also anticipates data from an updated i60 ITI application Cartridge. Moreover, the company is planning the launch of a comprehensive blood culture panel combining Gram-positive and Gram-negative pathogen markers as well as resistance markers by the end of 2015 in Europe.

The company also announced an update on its US trial of the Unyvero  LRT lower respiratory tract infection application. Curetis has adapted its FDA trial design to reflect the new guidelines issued by the FDA for multiplexed infectious diseases tests and will re-initiate prospective sample measurement once the enhanced and expanded P55 Pneumonia Cartridge is available as LRT-labeled test cartridges for the US FDA trial. Patient sample collection with the updated LRT application based on the P55 assay is expected to start mid-2015.

Curetis has decided to un-blind all data generated in its FDA trial to date and has engaged its network of US trial sites to continue collecting retrospective specimen. Data from the previous LRT study based on the P50 panel will be analyzed and published in a peer-reviewed format.

The new FDA guideline reduces the minimum number of required prospective patient samples to 1,500, limits requirements for prospective samples to only specificity endpoints, allows testing of retrospectively collected patient samples for sensitivity endpoints, and provides clarity on positive and negative control samples. Based on the adapted design and a start of patient sample collection with the new LRT55 application, which is anticipated by mid-2015, Curetis is expecting completion of patient enrolment in the first half of 2016, with subsequent filing with the FDA.


Company News: Curetis Presents New Unyvero Pneumonia Data at Major Clinical Microbiology Meetings

Presentation of clinical data from a pneumonia study on multi-pathogen infections at ICAAC 2014 and DGHM 2014

– Rapid Multiplex PCR assays confirmed as valuable addition to conventional testing methods

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced new data on the clinical performance of its Unyvero P50 pneumonia cartridge in multi-pathogen infections.

A study conducted by researchers from private laboratory medicine firm MVZ Dr. Eberhard & Partner (Dortmund, Germany) analyzed pneumonia patient samples with both Curetis’ Unyvero P50 pneumonia cartridge and with classical microbiology culture. The investigator-initiated study determined >80% sensitivity at >95% specificity for pathogen identification with Unyvero P50. Of note, 54% of all cases had polymicrobial infections, many of them involving between 3 and 6 different pathogens. In the trial, Unyvero P50 found additional polymicrobial infections and detected 17 pathogens, all of which were not identified by microbiology culture. In contrast, in 6 cases classical culture identified a total of 8 pathogens not detected by Unyvero P50.

The data have been presented at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington D.C.  (U.S.) and will also be presented at the upcoming conference Microbiology and Infection 2014 in Dresden (Germany), a joint event of the Association for General and Applied Microbiology (VAAM) and the Society of Hygiene and Microbiology (DGHM).

During Microbiology and Infection 2014, Curetis will host a symposium on the “Clinical Relevance of Rapid Infectious Disease Diagnostics”. It will take place on Monday, October 6, from 12:15pm – 1:15 pm CET (Room: Konferenz 1 / International Congress Center Dresden). The symposium will be chaired by Prof. Dr. Helmut Fickenscher (Kiel University). Presentations will be held by Dr. Reno Frei (University of Basel) and Prof. Dr. Maria Déja (Charité – Universitaetsmedizin Berlin).

Company News: Curetis AG Initiates Clinical Trial in the U.S. Towards FDA Clearance

– Prospective Multi-Center Trial to Enroll Over 2,000 Clinical Samples –

Curetis AG today announced the start of a clinical trial of its Unyvero™ System and the corresponding LRT (lower respiratory tract) application in the U.S. The company expects enrollment completion within the next 12-15 months, followed by a 510(k) submission to the FDA in 2014.

The prospective, multicenter trial will include samples collected from more than 2,000 hospitalized patients suspected to have a lower respiratory tract infection and several hundred retrospective samples with known microbiology culture results for rare pathogens. Samples will be processed by the Unyvero™ Lysator, transferred to the LRT cartridge, and tested by the Unyvero™ Analyzer.

Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to microbiology culture (today’s diagnostics standard of care) and to a composite reference diagnosis that incorporates PCR and sequencing to determine clinical truth whenever microbiology culture results are negative.

Trial sites include Northwestern University (Chicago, IL) and North Shore-LIJ Health System (Lake Success, NY), among others. The Principal Investigator is Prof. Christine C. Ginocchio, Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System. Curetis has contracted Aptiv Solutions as its CRO and Neil Mucci of GlobalBioclinical as project manager in the US.

The LRT application analyzes 39 DNA targets simultaneously from a single patient sample. Results are available within about 4 hours. The pathogen panel has been selected for clinical relevance based on current international clinical guidelines and has been reviewed by clinical experts in Europe and the USA. Resistance genes were chosen by frequency and clinical significance. A similar product, the Unyvero™ P50 pneumonia cartridge is CE-marked and currently marketed in Europe and the Middle East.


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