CE-IVD marking of the Respiratory Bacterial ELITe MGB® Panel for the detection of M.pneumoniae, C.pneumoniae and L.pneumophila

Puteaux, France, 12th February 2017 – ELITechGroup Molecular Diagnostics announces today the launch of a high-performance multiplex assay, Respiratory Bacterial ELITe MGB^® Panel, for the diagnosis of bacterial respiratory infections, validated with ELITe InGenius^®, ELITechGroup’s fully automated sample to result system. Respiratory infections are common causes of morbidity and mortality worldwide. Regardless of the pathogen involved, similar symptoms can be observed making the diagnosis difficult to establish from only considering a symptom-based approach. Using a molecular diagnostic method is crucial to effectively determine the pathogens involved, prevent the misuse of antibiotics, and ensure an optimal patient management. In combination with ELITe InGenius, the Respiratory Bacterial ELITe MGB^® Panel is the first panel specifically designed to detect main relevant respiratory bacteria, CE-IVD validated with a sample-to-result system. Respiratory Bacterial ELITe MGB^® Panel detects and differentiates in one single reaction M. pneumoniae, C. pneumoniae, and L. pneumophila. The clinical study has demonstrated excellent performance: 100% diagnostic sensitivity and 100% diagnostic specificity were obtained with all targets. The validation with ELITe InGenius offers many advantages to laboratories in comparison to other solutions available on the market: fully automated workflow from extraction to result interpretation, hands-on time reduced to few minutes, and accurate results. “We are proud to extend the ELITe InGenius respiratory menu which now enables laboratories to diagnose the main relevant virus and bacteria involved in respiratory infections. Aligned with our menu expansion strategy, this new assay strengthens the ELITe InGenius offer providing our customers with the largest CEIVD menu for infectious disease testing available on an integrated sample-to-result solution” commented Christoph Gauer, CEO of ELITechGroup. The CE-IVD ELITe InGenius respiratory menu will be further broadened in the coming months with a new Real-Time PCR assay for the detection of Mycobacterium tuberculosis and associated multidrug resistant forms to rifampicin, and isoniazid.