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.
The assay runs on a range of PCR instruments including Roche's LightCycler 480 II, Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx and QuantStudio 5 systems, and Agilent's Aria Mx and Stratagene Mx3005P systems. Results are provided within 20 minutes, LumiraDx said.
The test may be used by any lab CLIA-certified to perform high-complexity tests, according to the FDA.
In August, LumiraDx received EUA from the FDA for the SARS-CoV-2 RNA STAR assay, which also detects the SARS-CoV-2 ORF1a gene but requires nucleic acid extraction. In addition, the company obtained EUA for a rapid antigen test that month.