iPLEX Pro High-Throughput, Low-Cost SARS-CoV-2 Panel Granted Emergency Use Authorization

The single-reaction panel targets five regions of the viral genome, providing the accuracy and sensitivity required in the evolving landscape of SARS-CoV-2 testing. Clinical laboratories can process more than 6,000 samples each day running the assay on a single MassARRAY instrument, making it one of the highest throughput SARS-CoV-2 tests available under the US FDA's Emergency Use Authorization program. Priced at under $10 per sample, the panel makes large-scale testing more accessible. With the panel's release, Agena aims to alleviate material shortages, enabling laboratories to accelerate testing without concerns about instrument or assay availability.

"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."

"As the number of people being tested increases, panel sensitivity will be critical to ensuring proper patient management," said Dr. Darryl Irwin, Vice President of Scientific Affairs. "The iPLEX Pro SARS-CoV-2 Panel exhibits a limit of detection of 0.3 copies per uL. Labs can test large numbers of samples without sacrificing accuracy."

"The unique characteristics of the Agena detection technology provide significant supply chain advantages," said 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 iPLEX Pro SARS-CoV-2 kits and MassARRAY systems are ready for immediate deployment and we are equipped to supply millions of tests each month."

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