Curetis Completes Development of Unyvero Cartridge for Intra-Abdominal Infections
– Highly multiplexed panel covers up to 112 diagnostic targets
– Third new panel developed within one year after IPO
Amsterdam, the Netherlands, and Holzgerlingen, Germany, January 04, 2017 – Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the completion of development of its fourth Application Cartridge. The Unyvero IAI Cartridge is designed for the diagnosis of severe intra-abdominal infections and covers up to 74 bacteria, 13 fungi, 3 toxins and 22 resistance markers. The panel includes molecular markers for, among others, Clostridium difficile,Clostridium perfringens, Aeromonas spp. as well as for difficult-to-cultivate strains such as Prevotella spp. and comprises important antibiotic resistance markers such as Colistin resistance marker mcr-1, Fosfomycin resistance marker fosA3 and Nitroimidazol resistance markers nimA and nimB.
Initial verification and validation testing using clinical samples as well as blood cultures showed very promising interim data. The Unyvero IAI Cartridge will be made available for further routine clinical testing to several European hospitals in Q1/2017 for final clinical CE performance evaluation. Commercial roll-out in Europe is expected following the launch during the ECCMID 2017 conference in April. The IAI Cartridge aims to support clinicians in the fast and reliable diagnosis of various severe conditions, including peritonitis, acute abdomen and acute pancreatitis, and addresses a market of up to 1.9 million patients in hospitalized settings in Europe and the U.S. per year. Together with the Unyvero System, the IAI Cartridge can process a broad variety of clinical samples, including tissue, positively flagged blood cultures, ascites and gastric juice.
Complicated intra-abdominal infections are a common problem. In Germany, there are about 150,000 cases of severe intra-abdominal infections per year. In the U.S., appendicitis alone affects about 33,000 patients per year and is responsible for more than 1 million hospital days. Every fourth case of severe sepsis or septic shock can be attributed to intra-abdominal infections, and various independent studies show an overall mortality rate of 7.5%.
„We are excited about the fourth successfully completed new cartridge development program for Unyvero,” said Dr. Achim Plum CCO of Curetis. “The IAI Cartridge complements our Pneumonia, ITI and BCU cartridges and expands our portfolio of applications for severe infections in hospitalized patients. It will not only allow existing Unyvero customers to further broaden the use of their systems, but it will also attract new customer segments.”
“With now four highly multiplexed Unyvero Application Cartridges available on the Unyvero System, we have made it a truly versatile platform,” said Dr. Oliver Schacht, CEO of Curetis. “The IAI panel is a unique and highly differentiated syndromic testing panel and will be followed by new panels in the areas of urinary tract infections, cardiology-related infections, sepsis host response and expanded panels in respiratory diseases in the coming years.”
CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on the Curetis Unyvero technology is currently available for sale in the United States of America or Canada. The analytical and clinical performance characteristics of any Curetis Unyvero product which may be sold at some future point in time in the U.S. have not yet been established.
Founded in 2007, Curetis is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost-effective products for diagnosing severe infectious diseases. The diagnostic solutions of Curetis enable rapid multi-parameter pathogen and antibiotic resistance marker detection in only a few hours, a process that today can take up to days or even weeks with other techniques.
To date, Curetis has raised EUR 44.3 million in an IPO on Euronext Amsterdam and Euronext Brussels and private equity funds of over EUR 63.5 million. Furthermore, Curetis has entered into a debt financing facility with EIB for up to EUR 25 million. The company is based in Holzgerlingen near Stuttgart, Germany. Curetis has signed collaboration agreements with Heraeus Medical and Cempra Inc. as well as several international distribution agreements covering many countries across Europe, the Middle East and Asia.
For further information, please visit www.curetis.com.
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