NEW YORK — LumiraDx said on Thursday that it has received CE marking for its 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, with results available within 20 minutes. It uses a non-isothermal nucleic acid amplification technique called qSTAR that the company says eliminates the need for nucleic acid purification or extraction.
LumiraDx received Emergency Use Authorization from the US Food and Drug Administration for the assay in October. That EUA was reissued earlier this year to provide improvement in the limit of detection and additional PCR system validations to allow labs to expand their testing capabilities, according to the London-based company.