Qiagen unveils European rollout of QIAstat-Dx
QIAGEN N.V. announced the European rollout of its next-generation QIAstat-Dx panel for one-step, fully integrated molecular analysis of gastrointestinal syndromes. The multiplex gastrointestinal panel, which QIAGEN has upgraded to now include comprehensive viral coverage, detects the 24 most common viral, bacterial and parasitic pathogens that cause GI infections. A respiratory panel for QIAstat-Dx analyzes 21 viral and bacterial pathogens including sub-types of influenza, coronaviruses, pneumonia and other targets, to differentiate the causes of acute respiratory tract infections. The QIAstat-Dx system, which already had received CE-IVD marking along with the gastrointestinal and respiratory panels, recently achieved registration in Australia and is being launched there. Plans for U.S. regulatory submission of QIAstat-Dx and both panels are on track for expected approval in 2019. QIAGEN also expects to introduce a QIAstat-Dx multiplex test for meningitis, with CE-IVD marking, in 2019. A deep menu of assays is under development for syndromic testing in oncology and other therapeutic areas.