Curetis N.V., a developer of molecular diagnostic products, has rolled out its new Unyvero BCU blood culture application cartridge in in Europe, the Middle East and Asia.
The market launch was supported by interim data from an external, prospective, multicenter evaluation comparing the performance of the BCU cartridge against the performance of conventional microbiology work-up of positive blood cultures that is ongoing at three European hospitals.
The interim analysis on approximately 100 patient samples demonstrated a 98 percent concordance with conventional microbiology. Additional pathogens that escaped detection by conventional microbiology were found in several cases.
On average, Unyvero results were available 24 hours earlier and in some cases up to two days earlier than results obtained by routine diagnostic methods. The data also confirm compatibility with most commonly used blood culture systems, including BacT/ALERT (BioMérieux) and BD BACTEC (Becton Dickinson), according to the company.
Curetis expects to finalize the prospective evaluation during the third quarter of 2016 and is planning to submit a joint publication with the clinical investigators of the study to a peer-reviewed medical journal.
“The new Unyvero Application for blood cultures has truly proven its worth in our microbiology laboratory, thanks to its broad coverage of pathogens, the identification of antibiotic resistances and its easy handling,” Dr. Monika Huber, senior physician and a clinical investigators of the study, commented. “Even with mixed infections, excellent results are obtained within a few hours.”
Curetis, with background in the fields of in-vitro diagnostics and medical technology, focuses on the development and commercialization of products for diagnosing severe infectious diseases. The company, which maintains corporate offices in the Netherlands and Germany, was founded in 2007.