LumiraDx has announced that its COVID-19 molecular assay, LumiraDx SARS-CoV-2 RNA STAR Complete, has been 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, utilises 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, said: “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 10 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.