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Curetis' Unyvero Intra-Abdominal Infection (IAI) Cartridge Receives CE Marking
Product to launch in EMEA at ECCMID Conference April 22-25, 2017 / IAI Panel covers up to 130 diagnostic targets
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."
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