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LumiraDx's SARS-CoV-2 Ag Test Receives WHO Emergency Use Listing

LumiraDx Ltd. (LMDX), a diagnostics company, announced Friday that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing or EUL by the World Health Organization in their latest response effort to combat COVID-19.

The decision by the WHO to include the LumiraDx SARS-CoV-2 antigen test in its EUL was based on an essential set of available quality, safety, and efficacy and performance data.

The LumiraDx antigen test joins a select group of antigen tests the WHO has included in its EUL and represents the first microfluidic assay to meet the criteria.

The LumiraDx antigen test is a microfluidic immunofluorescence assay that delivers results for the direct and qualitative detection of nucleocapsid protein antigen in nasal swab specimens collected from the patient.

The test is used with the LumiraDx multi-assay Platform. It delivers rapid results at the point of care enabling physicians to immediately commence appropriate treatment and patient management to maximize health outcomes and minimize further spread of infection.

In clinical studies, the test demonstrated 95% positive agreement versus RT-PCR in patients tested within 12 days of the onset of symptoms.

LumiraDx, through a partnership with the Bill and Melinda Gates Foundation, has already distributed 5,000 Platforms in 49 African countries in various care settings.

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