The new EUA status allows the Lyra Direct SARS-CoV-2 Assay to apply a reformulated buffer that replaces the extraction step with a 10-minute heat step


Quidel has secured FDA EUA status for Lyra Direct assay to detect Covid-19 without extraction step. (Credit: Gerd Altmann from Pixabay)

Quidel has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Lyra Direct SARS-CoV-2 Assay for molecular detection of Covid-19 disease without the extraction step.

The EUA status enables to carry out direct sample processing with the Lyra Direct SARS-CoV-2 Assay. It helps to avoid an up-front sample extraction step.

As part of the new EUA, the Lyra Direct SARS-CoV-2 Assay applies a reformulated buffer, which replaces the extraction step with a simple 10-minute heat step, enabling to save around 50 minutes processing time.

The Lyra Direct SARS-CoV-2 Assay holds the capacity to run on seven different thermocyclers

The assay holds the capacity to run on any 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.

Separately, the company also recently secured CE mark approval for the Lyra Direct SARS-CoV-2 Assay to market in Europe, as well as other countries that accept the CE mark.

Earlier this month, Quidel secured EUA status from the FDA for its rapid antigen Covid-19 diagnostic assay.

The FDA EUA status allows the company’s Sofia 2 SARS Antigen FIA rapid point-of-care test to be used with the Sofia 2 fluorescent immunoassay analyser to rapidly detect SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Prevention’s (CDC) criteria for suspected COVID-19 infection.

Quidel’s molecular diagnostic brands include Sofia, QuickVue, D3 Direct Detection, Thyretain, Triage, InflammaDry, Solana, AmpliVue and Lyra.

The company’s products help to detect and diagnose multiple critical diseases and conditions such as influenza, respiratory syncytial virus, Strep A, lyme, herpes, pregnancy, thyroid disease, and fecal occult blood.