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Home » Business, Policy & Funding » Business News » LumiraDx Gets FDA Emergency Use Authorization for PCR-Based Coronavirus Test

LumiraDx Gets FDA Emergency Use Authorization for PCR-Based Coronavirus Test

Oct 19, 2020
|
staff reporter

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for LumiraDx's SARS-CoV-2 RNA STAR Complete assay.

The PCR-based test is designed to detect a region in the SARS-CoV-2 ORF1a gene in upper respiratory specimens. According to Waltham, Massachusetts-based LumiraDx, it uses a non-isothermal nucleic acid amplification technique called qSTAR that does not require nucleic acid purification or extraction.

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