Research & Development
Agena Bioscience awarded FDA's EUA for high-throughput, low-cost SARS-CoV-2 panel
29 October 2020 -

Genetic analysis systems company Agena Bioscience reported on Wednesday the receipt of the Emergency Use Authorization from the US Food and Drug Administration (FDA) for its MassARRAY SARS-CoV-2 Panel for qualitative detection of the SARS-CoV-2 coronavirus.

Clinical laboratories can process thousands of samples each day for less than USD10 per sample running the assay on the company's single MassARRAY instrument, making it one of the highest throughput SARS-CoV-2 tests available under the FDA's EUA programme.

The company added that the single-reaction panel targets five regions of the viral genome and provides excellent accuracy and sensitivity. It also aims to alleviate material shortages, enabling laboratories to accelerate testing without concerns about instrument or reagent availability.

According to the company, the MassARRAY 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.



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