HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the European rollout of its next-generation QIAstat-Dx® panel for one-step, fully integrated molecular analysis of gastrointestinal (GI) 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.
“Hospitals, laboratories and clinics are embracing QIAstat-Dx as an easy-to-use, next-generation solution for reliable diagnosis of complex syndromes. With less than one minute of hands-on time and results in about an hour, a clinic assistant or technician can run multiple samples and gain reliable, highly sensitive molecular insights that differentiate the causes of respiratory or gastrointestinal syndromes,” said Thierry Bernard, QIAGEN’s Senior Vice President, Molecular Diagnostics Business Area. “The simplicity of QIAstat-Dx brings the power of real-time PCR (polymerase chain reaction) technology close to the patient. A user just inserts a sample cartridge and walks away, and the instrument automatically handles all of the steps of multiplex molecular analysis – enabling the clinician to make informed treatment decisions.”
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