Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19

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Quidel has been given emergency use authorization from the US Food and Drug Administration (FDA) for its Lyra Direct SARS-CoV-2 Assay to be used for the molecular detection of COVID-19.

According to the diagnostic healthcare products manufacturer, the EUA status enables the Lyra Direct SARS-CoV-2 Assay for carrying out direct sample processing without the extraction step.

Under the new EUA, the Lyra Direct SARS-CoV-2 Assay can apply a reformulated buffer that replaces the extraction step by following a 10-minute heat step, thereby saving around 50 minutes of processing time.

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Quidel said that the assay can be done on any one of seven thermocyclers, including 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.

Quidel's Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19

Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19. Image courtesy of Daniel Roberts from Pixabay.

In a separate development, the diagnostic healthcare products manufacturer has received the CE mark approval for the Lyra Direct SARS-CoV-2 Assay recently to market and sell it in Europe and other countries that accept the CE mark.

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Earlier this month, Quidel was granted EUA status by the FDA for Sofia 2 SARS Antigen FIA, its rapid antigen COVID-19 diagnostic assay.

The EUA status from FDA permits the SARS Antigen FIA rapid point-of-care test to be done with the Sofia 2 Fluorescent Immunoassay Analyzer to quickly detect SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the criteria of the Centers for Disease Control and Prevention for suspected COVID-19 infection.

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