Agena Bioscience Granted EUA for High-Throughput SARS-CoV-2 Panel

Agena Bioscience® announced its MassARRAY® SARS-CoV-2 Panel for qualitative detection of the SARS-CoV-2 coronavirus has been granted Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).

Clinical laboratories can process thousands of samples each day for less than $10 per sample running the assay on a single MassARRAY instrument, making it one of the highest throughput SARS-CoV-2 tests available under the Emergency Use Authorization program.

"Agena is proud to offer a truly scalable platform to support the increasing demand for high-throughput SARS-CoV-2 testing," said Peter Dansky, CEO of Agena Bioscience. "To address the crisis presented by COVID-19, labs need to cost-effectively process large numbers of samples. The MassARRAY System is the perfect tool for that."

The single-reaction panel targets five regions of the viral genome and provides excellent accuracy and sensitivity.

"The MassARRAY SARS-CoV-2 Panel is the only assay on the market with 5 viral genome targets multiplexed into a single reaction, making it robust against potential mutations arising in the viral genome," said Dr. Darryl Irwin, Vice President of Scientific Affairs. "Most real time qPCR-based assays target only two or three targets on the viral genome."