LumiraDx Receives CTDA Approval for its LumiraDx Dual-Target SARS-
CoV-2 STAR Complete

The Fast Lab Solutions molecular test provides results within 20 minutes, supporting labs’ efficiency and productivity

December 15, 2022 (London): LumiraDx Limited (Nasdaq: LMDX) today announced its Fast Lab Solutions molecular test, the Dual-Target SARS-CoV-2 STAR Complete  has been successfully validated by the UK Coronavirus Test Device Approvals (CTDA).

The Dual-Target SARS-CoV-2 STAR Complete assay simultaneously detects two gene markers to identify the presence of SARS-CoV-2, which meets certain regulatory requirements in numerous regions that need two or more genetic SARS-CoV-2 targets for the detection of a COVID-19 diagnosis. Compared to a high sensitivity RT-PCR assay, Dual-Target SARS-CoV-2 STAR Complete, proved to have a PPA of 97.7% for SARS-CoV-2 and a NPA of 100% in symptomatic individuals.

LumiraDx’s continued innovation of its qSTAR technology, which utilizes a direct amplification method for nucleic acid extraction and amplification on validated open RT-PCR instruments, drove the development of this improved and new assay. Additionally, through this technology the turnaround time for the Dual-Target SARS-CoV-2 STAR Complete assay is within 20 minutes or less, enabling 94 patient results to be run on one RT-PCR instrument, compared to more than three hours for most molecular assays.

David Walton, Chief Commercial Officer, LumiraDx explained, “With this recent approval, we are happy to be able to further support the UK healthcare system with our expanded menu of COVID-19 testing solutions. The CTDA approval of the Dual-Target SARS-CoV-2 STAR Complete allows us to provide our service partners with high throughput, high sensitivity, and high efficiency COVID-19 molecular testing and now, with two gene markers. This test also enables an unprecedented throughput for laboratories, saving them time and dramatically increasing their efficiencies.”

Earlier this year, LumiraDx also received UK CTDA approval for its Fast Lab Solutions SARS-CoV-2 RNA STAR Complete Test.

About LumiraDx Fast Lab Solutions

LumiraDx Fast Lab Solutions supports high-complexity laboratory testing by utilizing its innovative qSTAR nucleic acid amplification technology in an accessible high-throughput format to leverage current molecular laboratory operations. Utilizing Fast Lab Solutions enables laboratories to improve efficiency and reduce time to result.

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 the pipeline, 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.

Colleen McMillen


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