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Medical Devices / Submissions and Approvals

Qiagen’s Syndromic Testing System Cleared by FDA

May 21, 2019
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The FDA granted Qiagen 510(k) clearance for its QIAstat-Dx syndromic testing system and respiratory assay panel for detection of multiple respiratory viral and bacterial pathogens. The panel provides simultaneous testing for more than 20 pathogens.

Syndromic testing with molecular diagnostics can identify illnesses that manifest as a set of symptoms with uncertain causes, such as influenza or pneumonia.

Qiagen said it expects to release numerous diagnostics for infectious diseases, oncology and other areas. The company plans to launch a gastrointestinal panel later this year.

The QIAstat-Dx system earned a CE-IVD Mark in January 2018.

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