Oct. 28, 2020—Agena Bioscience‘s MassArray SARS-CoV-2 Panel for qualitative detection of the SARS-CoV-2 coronavirus has been granted emergency use authorization from the FDA.
Clinical laboratories can process thousands of samples a day for less than $10 per sample running the assay on one MassArray instrument, the company says.
With the panel’s authorization, Agena also aims to alleviate material shortages, enabling laboratories to accelerate testing without concerns about instrument or reagent availability.
“The unique characteristics of the Agena detection technology provide significant supply chain advantages,” Jason Halsey, senior vice president of technology and operations, Agena Bioscience, said in a press release. “Agena proactively sourced and secured materials to provide uninterrupted product availability to our customers. Agena’s MassArray SARS-CoV-2 Panel kits and instruments are ready for immediate deployment, and we are equipped to supply millions of tests each month.”
The single-reaction panel targets five regions of the viral genome and provides excellent accuracy and sensitivity.