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May 19, 2020

Quidel receives EUA for Lyra Direct Covid-19 test

Quidel has received EUA from the US Food and Drug Administration (FDA) for the Lyra Direct SARS-CoV-2 Assay to allow direct Covid-19 test sample processing.

Quidel has received EUA from the US F ood and Drug Administration (F DA) for the Lyra Direct SARS-CoV-2 Assay to allow direct Covid-19 test sample processing.

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The assay was designed for molecular detection of Covid-19.

According to the new EUA, the Lyra Direct SARS-CoV-2 removes RNA extraction processing step and supply bottleneck and no longer requires an upfront sample extraction.

A reformulated buffer used by the assay replaces the extraction step with a simple heat step that takes ten minutes.

The Lyra Direct SARS-CoV-2 Assay retains its versatility and can run on any of seven possible thermocyclers.

The thermocyclers include Applied Biosystems 7500 Standard, Applied Biosystems 7500 F ast, Bio-Rad CF X96 Touch, Qiagen Rotor-Gene Q, Roche LightCycler 480, Roche Cobas z480 and Thermo F isher QuantStudio 7 Pro.

Additionally, the Lyra Direct assay has received CE Mark, which allows Quidel to market and sell it in Europe and other countries where CE Mark is accepted.

Currently, the test is available for sale in the US under EUA. Laboratory professionals can buy the assay through Quidel directly or through its Cardinal Health representative.

The latest development comes after the F DA granted expanded EUA for the Lyra SARS-CoV-2 Assay for Covid-19 diagnosis. It will enable testing with three additional thermocyclers – Applied Biosystems 7500 Standard, Roche LightCycler 480 and Qiagen Rotor-Gene Q.

Last week, Quidel received EUA from the F DA to market its Sofia 2 SARS Antigen F IA, a rapid, point-of-care test to diagnose Covid-19. It will be used with Sofia 2 F luorescent Immunoassay Analyser for rapid detection of SARS-CoV-2 virus in nasal or nasopharyngeal specimens from patients with symptoms of the virus.

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COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
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