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

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.