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NEW YORK – Helix said on Monday that the US Food and Drug Administration has granted Emergency Use Authorization for the firm's next-generation sequencing-based COVID-19 test.

Helix's in vitro diagnostic assay is designed to detect the SARS-CoV-2 spike protein gene (and an internal human control, RPP30) in upper respiratory specimens including nasopharyngeal swabs, oropharyngeal swabs, mid-turbinate nasal swabs, and anterior nasal swabs.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.