Qiagen gets FDA nod for syndromic SARS-CoV-2 test

2020 03 31 18 05 5944 2020 03 31 Qiagen Qi Astat Covid 19 20200331181326

Qiagen has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its QIAstat-Dx diagnostic kit, a syndromic test for detecting the SARS-CoV-2 virus.

QIAstat-Dx is a multiplexed nucleic acid test that differentiates SARS-CoV-2 from 21 other bacterial and viral pathogens implicated in respiratory syndromes in about an hour. The test evaluates samples such as nasopharyngeal swabs and includes assays targeting two genes used to detect SARS-CoV-2.

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