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February 21, 2022updated 22 Jul 2022 6:37am

UK’s MHRA approves LumiraDx’s SARS-CoV-2 RNA STAR Complete

The new molecular assay uses a one step direct method for extracting and amplifying nucleic acid on open RT-PCR instruments.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved LumiraDx’s SARS-CoV-2 RNA STAR Complete.

Developed with non-isothermal nucleic acid amplification qSTAR technology, the new rapid Covid-19 molecular assay is designed to detect nucleic acid from SARS-CoV-2 in upper respiratory swabs collected from Covid-19 suspects by a healthcare provider (HCP).

It uses a one step direct method for extracting and amplifying nucleic acid on validated open RT-PCR instruments.

Validated by Coronavirus Test Device Approvals (CTDA), LumiraDx SARS-CoV-2 RNA STAR Complete provides results within 20 minutes and contributes to the efficiency and productivity of labs.

The new assay is also authorised for use by non-symptomatic individuals, as well as others without reason to suspect Covid-19, when either self-collected under a HCP’s supervision or by a HCP.

The test showed a positive agreement of 95.4% compared to another high sensitivity RT-PCR assay in clinical trials.

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.”

The company’s SARS-CoV-2 Antigen Test also received UK CTDA and MHRA approval earlier this month.

Last month, LumiraDx announced that its Covid-19 antigen test is capable of detecting the Omicron variant.

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