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