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

Agena Bioscience®, a global provider of low-cost and high-throughput molecular testing solutions, announced that 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."

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," explained Jason Halsey, Senior Vice President of Technology and Operations. "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."

About Agena Bioscience

Agena Bioscience develops, manufactures, and supplies genetic analysis systems and reagents, including the MassARRAY® System. The system is a highly sensitive, cost-effective, mass spectrometry-based platform for high-throughput genetic analysis and is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research.