Curetis' Unyvero Intra-Abdominal Infection (IAI) Cartridge Receives CE Marking

Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced the successful completion of clinical performance evaluation and CE-IVD marking of its fourth Unyvero Application Cartridge for the diagnosis of severe intra-abdominal infections (IAI). The IAI Cartridge covers up to 92 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., that are often overlooked in the presence of aerobic / fast-growing microorganisms. It also comprises important antibiotic resistance markers such as Colistin resistance marker mcr-1, Fosfomycin resistance marker fosA3 and Nitroimidazol resistance markers nimA and nimB.

The prospective, multi-center study to evaluate clinical performance was conducted over the past few months at major hospitals in the UK, in France, and Italy. In total, 332 patient samples were tested and 679 pathogens were determined as true positives using the Unyvero IAI Application Cartridge. Overall weighted average sensitivity for the pathogens specifically targeted by the test panel was 93.8% at an overall weighted average specificity of 99.7% following discrepant result resolution.

A particular strength of the IAI cartridge is the reliable detection of anaerobic bacteria that are notoriously hard to cultivate and thus often missed by routine microbiological culture. Further, the Unyvero IAI has also demonstrated the ability to deliver results on pathogens, toxins, and resistance markers much faster than microbiology culture, the current standard of care.

The IAI Cartridge aims to support clinicians in the fast and reliable diagnosis of various severe conditions, including peritonitis, cholecystitis 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, ascites in positively flagged blood cultures, and gastric juice.

Complicated intra-abdominal infections are a common problem. In Germany alone, there are about 150,000 cases of severe intra-abdominal infections per year. In the U.S., appendicitis alone affects about 300,000 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 this fourth unique application now being launched for our Unyvero System," said Dr. Achim Plum, CCO of Curetis. "The IAI Cartridge complements our Pneumonia, ITI and BCU cartridges, and further 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 groups."

Dr. Oliver Schacht, CEO of Curetis, added, "The IAI panel is a first in class and highly differentiated syndromic testing panel and will be followed by new panels in the areas of severe urinary tract infections, sepsis host response, expanded panels in respiratory diseases and cardiology-related infections in the coming years."

Disclaimer

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.

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