LumiraDx has received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approval for its rapid Covid-19 molecular assay, SARS-CoV-2 RNA STAR Complete.

The approval has been granted under the Coronavirus Test Device Approvals (CTDA) legislation.

LumiraDx SARS-CoV-2 RNA STAR Complete has been developed using its unique qSTAR technology, said the company.

The assay leverages a single step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments, and delivers results within 20 minutes.

In the clinical trials, the rapid Covid-19 assay showed 95.4% positive agreement compared to another high sensitivity RT-PCR assay, said LumiraDx.

LumiraDx chief commercial officer David Walton 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 CDTA 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.”

LumiraDx Fast Lab Solutions has developed the at-home self- collection solution for use with SARS-CoV-2 RNA STAR Complete, in partnership with Audere.

Audere is a non-profit digital health organisation that develops HealthPulse@home solution, which complements LumiraDx’s efforts to increase testing access and support.

LumiraDx Fast Lab Solutions is a dedicated business unit of LumiraDx that supports high-complexity laboratory testing using advanced qSTAR nucleic acid amplification technology.

The SARS-CoV-2 RNA STAR Complete has been authorised by the US Food and Drug Administration (FDA) for emergency use (EUA) by authorised laboratories.

Established in 2014, LumiraDx is a next-generation point of care diagnostics company focused on community-based healthcare.

It manufactures and commercialises an advanced diagnostic Platform that supports a wide portfolio of point of care tests, with lab comparable performance.