Quidel nets EUA, CE Mark for Lyra Direct SARS-CoV-2 assay

2020 02 25 17 48 0053 Thumbs Up New 400

Quidel has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and the CE Mark for its Lyra Direct SARS-CoV-2 assay, a new version of its Lyra real-time reverse transcription polymerase chain (RT-PCR) test that skips upfront sample extraction.

With Lyra Direct, the RNA extraction processing step is replaced by a reformulated buffer with a 10-minute heat step, saving approximately 50 minutes in processing time, according to the company. As was the case with Quidel's original Lyra SARS-CoV-2 assay, Lyra Direct can be run on seven thermocyclers, including 7500 Standard and 750 Fast (Applied Biosystems), CFX96 Touch (Bio-Rad), Rotor-Gene Q (Qiagen), LightCycler 480 and Cobas z480 (Roche), and QuantStudio 7 Pro (Thermo Fisher).

Lyra Direct is available now in the U.S.

Page 1 of 11
Next Page