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Curetis Gets CE-IVD Mark for Blood Culture Cartridge

NEW YORK (GenomeWeb) – Curetis said today that it recently received the CE-IVD mark for its Unyvero BCU Blood Culture Application Cartridge and has launched the test in Europe, the Middle East, and Asia.

The company said the launch was supported by interim data from an external, prospective, multicenter evaluation comparing the cartridge to conventional microbiology work-up of positive blood cultures in 100 patient samples. The cartridge demonstrated a 98 percent concordance with conventional microbiology, and further detected additional pathogens in several cases that conventional microbiology missed, the company said in a statement. On average, Curetis added, Unyvero results were also available more quickly than routine diagnostic methods.

The BCU Application Cartridge covers more than 100 diagnostic targets, including tests detecting up to 87 pathogens including Gram-positive and Gram-negative bacteria, fungi and mycobacteria, as well as tests for up to 16 antibiotic resistance biomarkers, according to Curetis. The cartridge is also compatible with most common commercial blood culture systems, including BioMérieux's BacT/Alert and BD's Bactec.

The company expects to finalize the prospective evaluation during the third quarter of 2016 and will submit a joint publication with the clinical investigators of the study to a peer-reviewed medical journal.

"We are very pleased with these first data from the prospective evaluation of our BCU Blood Culture Application," said Curetis COO Achim Plum in a statement. "They demonstrate the versatility and utility of our new BCU Application Cartridge in the rapid and reliable identification of pathogens and antibiotic resistance markers in positively flagged blood cultures. The results also indicate its significant potential to improve the management of critically ill patients with blood stream infections."

In March, the company told GenomeWeb it also plans to take advantage of the momentum from its November IPO on Euronext to launch additional products and to establish a US operation in advance of potential US Food and Drug Administration clearance of its Unyvero sample-to-answer molecular diagnostics platform and initial test for lower respiratory tract infections.