LumiraDx's COVID Ultra and COVID & RSV Tests Granted UK CTDA Approval

Wednesday, June 21, 2023

LumiraDx Limited has announced the validation of its LumiraDx SARS-CoV-2 Ag Ultra and LumiraDx SARS-CoV2 Ag & RSV tests by the MHRA under the CTDA process. This validation supports the UK in preparing for the upcoming respiratory season by providing tests that enable rapid detection of SARS-CoV-2 infection and differentiation between SARS-CoV-2 and RSV when respiratory symptoms are present.

The LumiraDx SARS-CoV-2 Ag Ultra test allows for the detection of SARS-CoV-2 infection within 5 minutes, making it a valuable tool for point-of-care use. It enables clinicians to test more patients accurately and efficiently, optimize clinical workflows, and expedite patient triage. The LumiraDx SARS-CoV2 Ag & RSV test allows for simultaneous detection and differentiation of RSV and SARS-CoV-2 infections. Since the clinical signs and symptoms of respiratory viral infections caused by SARS-CoV-2 and RSV can be similar, accurate identification is essential, particularly for young infants affected by RSV, to ensure appropriate treatment and management.

The LumiraDx SARS-CoV-2 Ag Ultra assay was launched in the European Union and other CE-IVD accepting markets in May 2022, followed by the LumiraDx SARS-CoV-2 Ag & RSV assay in the same month. The company plans to begin commercialization of these tests in the UK and initiate commercial shipments soon.

David Walton, Chief Commercial Officer of LumiraDx, expressed excitement about making these tests commercially available to the NHS and other customers, aiming to reduce the burden of respiratory illnesses, improve clinical workflows, and enhance patient outcomes during the respiratory season planning.

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