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

Agena Bioscience, a global provider of low cost and high-throughput molecular testing solutions, today announced the launch of the iPLEX Pro SARS-CoV-2 Panel for qualitative detection of the novel coronavirus that causes COVID-19. Clinical laboratories can process more than 6000 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 U.S. Food and Drug Administration’s Emergency Use Authorization program. Priced at under $10 per sample, the panel makes large-scale testing more accessible. 
 
“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, providing the accuracy and sensitivity required in the evolving landscape of SARS-CoV-2 testing.
 
“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.”
 
With the panel’s release, Agena also aims to alleviate material shortages, enabling laboratories to accelerate testing without concerns about instrument or assay 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 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.”