NEW YORK (GenomeWeb) – Curetis said today that based on a performance evaluation for the newest version of its Unyvero ITI Implant and Tissue Infection Application Cartridge, it has marked the cartridge as conforming with previous CE-IVD Marking. The firms also plans to launch the new generation cartridge internationally in the third quarter of 2016.
The new Unyvero ITI has an extended panel and increased sensitivity, the company said. The cartridge is designed to diagnose various severe infections, including prosthetic joint infections, surgical site infections, catheter-associated infections, and skin and soft tissue infections. The first-generation cartridge was launched in 2014 and covered a total of 80 diagnostic targets. The cartridge now covers 102 diagnostic targets including 85 pathogenic microorganisms such as Gram positive and Gram negative bacteria, several fungi, and 17 related antibiotic resistance markers.
The new version of the cartridge also now has a universal bacterial primer, several Candida species, various types of Streptococci, Klebsiella variicola, and other new diagnostic targets. In addition, clinical sensitivity has been significantly improved for many key pathogens, Curetis said.
In order to conform to CE marking, the firm conducted a performance evaluation study for the cartridge, evaluating its performance on 1,100 samples, including 700 samples positive for microbial growth in routine patient work-ups. The study demonstrated an overall sensitivity for all pathogens of 86.9 percent and an overall specificity for all pathogens of 99.2 percent, according to the company.
"We are excited to start marketing the new ITI Application Cartridge for our Unyvero Platform," said Chief Commercial Officer Achim Plum in a statement. "With more than 100 diagnostic targets covered by the new Unyvero ITI cartridge, we believe we have a solution with the broadest available panel for suspected implant and tissue infections and an unmatched versatility allowing the use of a wide range of routine clinical patient sample types."
In June, Curetis reported that it had received CE-IVD marking for its Unyvero BCU Blood Culture Application Cartridge covering more than 100 diagnostic targets including up to 87 pathogens such as Gram-positive and Gram-negative bacteria, fungi, and mycobacteria.