Skip to main content
Premium Trial:

Request an Annual Quote

LumiraDx Gets CE Mark for Molecular SARS-CoV-2 Test

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.

The Scan

Support for Moderna Booster

An FDA advisory committee supports authorizing a booster for Moderna's SARS-CoV-2 vaccine, CNN reports.

Testing at UK Lab Suspended

SARS-CoV-2 testing at a UK lab has been suspended following a number of false negative results.

J&J CSO to Step Down

The Wall Street Journal reports that Paul Stoffels will be stepping down as chief scientific officer at Johnson & Johnson by the end of the year.

Science Papers Present Proteo-Genomic Map of Human Health, Brain Tumor Target, Tool to Infer CNVs

In Science this week: gene-protein-disease map, epigenomic and transcriptomic approach highlights potential therapeutic target for gliomas, and more