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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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