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

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  • 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.

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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.”

About LumiraDx

LumiraDx Limited (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Its actively controlled microfluidic technology provides fast, high performance and accessible diagnostic solutions wherever the patient is for nearly any testing scenario, creating unique testing options at the point of need. The company offers a broad menu of lab comparable tests on a single portable Platform, with more than 30 assays on the market and in various stages of development, covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders. The company also supports high-complexity laboratory testing in an accessible high-throughput format to leverage current molecular laboratory operations. Founded in 2014 and based in the UK, LumiraDx’s diagnostic testing solutions are being deployed globally by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to help screen, diagnose, and monitor wellness as well as disease. More information on LumiraDx is available at www.lumiradx.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the performance and benefits of the LumiraDx SARS-CoV-2 Ag Ultra and LumiraDx SARS-CoV2 Ag & RSV tests and the timing of commercial launch and shipments of certain products. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including, among others, general economic, political and business conditions; changes in interest rates, inflation rates and global and domestic market conditions; the effect of COVID on our business and financial results; obtaining or maintaining regulatory approval, authorization or clearance for our tests; and those factors discussed under the header “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2022, which was filed with the Securities and Exchange Commission, or SEC, on May 1, 2023, and in other filings that we make with the SEC. Although LumiraDx believes that it has a reasonable basis for each forward-looking statement contained in this press release, LumiraDx cautions you that these statements are based on a combination of facts and factors currently known by it and its projections of the future, about which it cannot be certain. LumiraDx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

*Not all tests are available in all countries and regions. For additional detail on product availability please visit www.lumiradx.com

CONTACT: Media Contact [email protected]

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