Tag: product updates 2015

Company News: Curetis Expands Commercial Organization

Augmented direct sales force, led by new Head of International Sales to broaden reach in key European markets

New distribution partnerships in Italy and Middle East

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the strategic expansion of its sales and marketing program in Europe and the Middle East. The company appointed Klaudija Kiesinger as Head of International Sales for Western Europe and will add four new members to its broader international sales and marketing team by mid-year, bringing the total commercial team size to 14. With this sales force expansion, Curetis has added the U.K., France and the Benelux region (Belgium, the Netherlands and Luxembourg) to its direct-sales markets.

In addition, the Company announced its increased reach into Italy and the Middle East with exclusive, multi-year distribution partnerships. Curetis will distribute the Unyvero Solution through Arrow Diagnostics in Italy and Al Zahrawi Medical in the Middle East (Qatar and the United Arab Emirates).

Since 2012, Curetis has grown to an installed base of more than 60 Unyvero analyzers. The Company currently has 80 systems in the supply chain for 2015, affording customers the potential to run assays covering more than 100 analytes in two highly-multiplexed application cartridges (P55 for pneumonia and i60 for implant and tissue infections). In 2015, the Unyvero product pipeline will be expanded and enhanced by the BC70 Blood Culture Application cartridge. In the coming years, Curetis plans to add further cartridge applications in the fields of sepsis, gastrointestinal tract infections, tuberculosis, CNS infections and pediatrics, among others.

At present, there are several investigator-initiated clinical studies in pediatric applications underway. Various potential pharma projects using Unyvero in clinical trial designs for the development of novel antibiotics afford Curetis additional opportunities for commercial expansion.

In addition to these platform and product enhancements, the Company is expanding its geographic scope, with an FDA trial underway in the U.S. and pre-commercial activities in Asia and other non-European countries.

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.