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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.
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 Fast, Bio-Rad CFX96 Touch, Qiagen Rotor-Gene Q, Roche LightCycler 480, Roche Cobas z480 and Thermo Fisher 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 FDA 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 FDA to market its Sofia 2 SARS Antigen FIA, a rapid, point-of-care test to diagnose Covid-19. It will be used with Sofia 2 Fluorescent Immunoassay Analyser for rapid detection of SARS-CoV-2 virus in nasal or nasopharyngeal specimens from patients with symptoms of the virus.