Research & Development
LumiraDx says SARS-CoV-2 Antigen test proven to detect Omicron Variant
17 January 2022 -

LumiraDx (Nasdaq: LMDX), a UK-based next-generation point of care diagnostics company, announced on Friday that the outcome from ongoing testing and monitoring of COVID-19 variants indicate that its SARS-CoV-2 Antigen test detects the Omicron Variant.

The company said that in-house wet testing with live Omicron virus indicated that the test detects the Omicron variant with comparable sensitivity to other variants. In the original United States Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) clinical studies, the test indicated 100% agreement with RT-PCR up to Ct 33.0.

The LumiraDx SARS-CoV-2 Antigen test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorised laboratories. The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

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