NEW YORK (GenomeWeb) – Curetis has received CE-IVD marking for its multiplex PCR-based assay for severe intra-abdominal infections. The firm plans to launch the test at upcoming conferences in Europe.
The IAI Cartridge is a panel that covers up to 130 targets, including 92 bacteria, 13 fungi, and 3 toxins. It can also detect 22 markers of drug resistance, such as colistin resistance marker mcr-1, fosfomycin resistance marker fosA3, and nitroimidazol resistance markers nimA and nimB. The assay runs on Curetis' Unyvero platform and accepts various clinical samples, such as tissue, ascites from positive blood cultures, and gastric juice.
The IAI test is able to detect anaerobic bacteria that are often missed by routine microbiological culture, and has demonstrated an ability to deliver results more quickly than culture-based methods. The panel was also recently evaluated in a prospective, multi-center study and was found to have a overall weighted average sensitivity and specificity of 93.8 percent and 99.7 percent, respectively, Curetis noted.
Common intra-abdominal infections include appendicitis, peritonitis, cholecystitis, and acute pancreatitis, and create a diagnostics market of up to 1.9 million patients per year in European and US hospital settings, the firm added.
The test is the fourth application on the Unyvero System. Other cartridge-based panel assays include the firm's pneumonia, ITI implant and tissue infection, and BCU blood culture tests.
Curetis Chief Commercial Officer Achim Plum noted in a statement that the new test expands Curetis' portfolio of applications for severe infections in hospitalized patients to four panels. "It will not only allow existing Unyvero customers to further broaden the use of their systems, but it will also attract new customer groups," Plum said.
The firm also noted that it has additional panels in development on the Unyvero system for severe urinary tract infections, sepsis host response, and expanded panels for respiratory diseases and cardiology-related infections. Curetis submitted a lower respiratory infection panel to the US Food and Drug Administration earlier this year.