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LumiraDx lab analysis confirms its Covid-19 antigen test detects the Omicron variant

London, UK
Monday, January 17, 2022, 12:00 Hrs  [IST]

LumiraDx, a next-generation point of care diagnostics company, announced that results from ongoing testing and monitoring of Covid-19 variants show its SARS-CoV-2 Antigen test detects the Omicron Variant. In-house wet testing with live Omicron virus demonstrated that the LumiraDx SARS-CoV-2 Antigen test detects the Omicron variant with comparable sensitivity to other variants. In the original US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) clinical studies, the test demonstrated 100% agreement with RT-PCR up to Ct 33.0. These latest testing results confirm the company’s previous announcement based on in-silico and recombinant protein analysis of the specific mutations in the Omicron variant that it was confident that the performance of its antigen and molecular tests will not be impacted by these mutations.

Nigel Lindner, PhD, chief innovation officer at LumiraDx commented, “Testing is a critical tool to control the spread of the virus and we have been committed to conducting research that confirms the sensitivity of our tests as soon as new variants emerge. We continuously monitor for Covid-19 variants and evaluate new ones as they appear through our in-house testing as well as through our collaborations with laboratory partners globally. The ability of our test to detect Omicron and other variants of concern, combined with both CE Marking and EUA from FDA with the intended use that includes the screening of asymptomatic individuals makes the LumiraDx SARS-CoV-2 Antigen test a valuable tool at this stage of the pandemic.”

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 authorized laboratories. The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of the product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of Covid-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

LumiraDx  is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, LumiraDx manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care.

 

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