LumiraDx Receives UK CTDA Approval for COVID Ultra and COVID & RSV Tests

• LumiraDx SARS-CoV-2 Ag Ultra & SARS-CoV-2 Ag & RSV tests have been successfully validated by the Medicines and Healthcare products Regulatory Agency (MHRA) under the Coronavirus Test Device Approvals (CTDA) process.
• These assays join the LumiraDx SARS-CoV-2 Ag and SARS-CoV-2 Ag & Flu A/B assays which have already been validated through the CTDA process.
• This portfolio of tests enables clinicians to identify and differentiate patients, optimise clinical workflows and help triage patients without delay.
• These assays are available on the LumiraDx Platform, with innovative strip design and microfluidic immunofluorescence technology, enabling rapid results without sacrificing sensitivity.

LONDON, June 20, 2023 (GLOBE NEWSWIRE) -- LumiraDx Limited (Nasdaq: LMDX) today announced that it has received validation for use by the MHRA under the CTDA process for the LumiraDx SARS-CoV-2 Ag Ultra and LumiraDx SARS-CoV2 Ag & RSV tests. This milestone supports the UK in preparing for the upcoming respiratory season with tests that allow for rapid detection of SARS-CoV-2 infection as well as helping to differentiate between SARS-CoV-2 and RSV when respiratory symptoms are present.

The LumiraDx SARS-CoV-2 Ag Ultra test allows for detection of SARS-CoV-2 infection within 5 minutes, making it a powerful tool at the point of care. The test enables clinicians to accurately and confidently test more patients, optimise clinical workflows and help triage patients without delay. The LumiraDx SARS-CoV2 Ag & RSV test allows for simultaneous detection and differentiation of RSV and SARS-CoV-2 infections. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and RSV can be similar, and as RSV normally affects young infants, it is essential to correctly identify them to treat and manage patients accordingly.

LumiraDx launched the LumiraDx SARS-CoV-2 Ag Ultra assay in the European Union and other markets that accept CE-IVD in May 2022 and the LumiraDx SARS-CoV-2 Ag & RSV assay in May 2022. The company expects to begin commercialisation of these tests in the UK and commence commercial shipments imminently.

“With planning for the respiratory season already underway in some regions, we are delighted to have these tests commercially available for the NHS and other customers,” explains David Walton, LumiraDx’s Chief Commercial Officer. “By providing rapid, high sensitivity point of care tests for COVID, Flu and RSV, we hope to reduce the burden of respiratory illness, facilitate optimised clinical workflows and improve patient outcomes.”