LumiraDx Receives UK MHRA Approval for SARS-CoV-2 RNA STAR Complete
February 21, 2022 (London): LumiraDx (Nasdaq: LMDX) announced today that its rapid COVID-19 molecular assay, LumiraDx SARS-CoV-2 RNA STAR Complete, has been successfully validated by Coronavirus Test Device Approvals (CTDA) and received UK Medicines and Healthcare products Regulatory Agency (MHRA) approval.
LumiraDx SARS-CoV-2 RNA STAR Complete, developed with proprietary qSTAR technology, utilizes a single step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments, with results within 20 minutes. In clinical studies, the assay demonstrated 95.4% positive agreement when compared to another high sensitivity RT-PCR assay.
David Walton, Chief Commercial Officer, LumiraDx states “Since the start of the pandemic, we have been pleased to support the UK healthcare system with our LumiraDx SARS-CoV-2 Antigen test, providing high sensitivity COVID-19 antigen testing in emergency departments, healthcare clinics, pharmacies, and nursing homes. With CTDA and MHRA approvals of LumiraDx SARS-CoV-2 RNA STAR Complete, we look forward to partnering with our service partners to provide high throughput, high sensitivity and high efficiency COVID-19 molecular testing. With the capability to process samples up to ten times faster than traditional RT-PCR methods, we are seeing broad customer demand for testing at multiple settings including airports, events and other public venues.”
Earlier this month, LumiraDx also received UK CTDA and MHRA approval for its SARS-CoV-2 Antigen Test.
About LumiraDx Fast Lab Solutions
LumiraDx Fast Lab Solutions is a dedicated LumiraDx business unit that 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.
LumiraDx (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, LumiraDx manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care. LumiraDx diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor wellness as well as disease. LumiraDx has on the market and in development, 30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform. In addition, LumiraDx has a comprehensive portfolio of fast, accurate, and cost-efficient COVID-19 testing solutions from the lab to point of need.
LumiraDx is based in the UK with more than 1600 employees worldwide.
Further information on LumiraDx and the LumiraDx Platform is available at www.lumiradx.com