Qiagen says prelim data shows effective pathogen detection by QIAstat-Dx

Qiagen announced new data of the QIAstat-Dx Meningitis / Encephalitis panel. The panel is in late stage development and being prepared for CE-IVD commercialization in the second half of 2019 for use on the QIAstat-Dx multiplex syndromic testing system. The preliminary data demonstrates effective detection of the most prevalent central nervous system pathogens with high analytical sensitivity and specificity levels, including the discrimination of clinically relevant strains and subtypes, the company said. This new test will expand the QIAGEN menu of diagnostic panels for syndromic testing, adding to CE-IVD marked DiagCORE tests for respiratory and gastrointestinal infections that were launched in 2018. The U.S. regulatory clearance of QIAstat-Dx is expected in mid-2019, and a deep menu of additional tests covering infectious diseases and other therapeutic areas is in development. “Our new QIAstat-Dx panel meets an urgent need for rapid and reliable diagnosis of meningitis and encephalitis infections, and will enable clinicians to select appropriate therapies in a timely manner. The panel delivers valuable insights with high sensitivity and specificity to identify these life-threatening syndromes,” said Thierry Bernard, Senior Vice President and Head of QIAGEN’s Molecular Diagnostics Business Area. “Laboratories in Europe are embracing the new platform and the power of syndromic testing based on proven PCR technologies to identify syndromic conditions with the simplicity of a true Sample to Insight solution. Demand for syndromic testing is growing rapidly, and we are developing a deep menu of assays to significantly increase the utility of QIAstat-Dx for an increasing range of applications.”
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