San Diego-based Agena Bioscience announced Wednesday that its diagnostic system for detection of SARS-CoV-2, the virus that causes COVID-19, received Emergency Use Authorization from the U.S. Food and Drug Administration.
The company was granted approval Monday on an emergency basis for its MassARRAY SARS-CoV-2 panel for use in clinical laboratories.
The FDA’s Emergency Use Authorization allows for the use of unapproved medical products during an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions. Emergency Use Authorization has been granted to a large number of companies since the COVID-19 pandemic began for rapid approval of diagnostic tests, personal protective equipment, ventilators and other devices.
“Agena is proud to offer a truly scalable platform to support the increasing demand for high-throughput SARS-CoV-2 testing,” said Agenda CEO Peter Dansky. “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 company, with operations in the University City area, says its panel targets five regions of the viral genome, and that with its authorization, the company hopes to help laboratories increase testing without the concerns of instrument or reagent availability.
“The unique characteristics of the Agena detection technology provide significant supply chain advantages,” said Jason Halsey, Agena’s 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.”
— City News Service
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