Agena Bioscience has secured the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its MassARRAY SARS-CoV-2 Panel to detect coronavirus.
The single-reaction panel is designed to target five regions of the viral genome and delivers enhanced accuracy and sensitivity.
The assay runs on a single MassARRAY instrument, a high-sensitive mass spectrometry-based platform used for high-throughput genetic analysis.
MassARRAY instrument is used in fields including cancer profiling, solid tumours and liquid biopsies, inherited genetic disease testing, pharmacogenetics, agricultural genomics, and clinical research, said the company.
Agena Bioscience CEO Peter Dansky said: “Agena is proud to offer a truly scalable platform to support the increasing demand for high-throughput SARS-CoV-2 testing. 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.”
Agena Bioscience scientific affairs vice president Darryl Irwin said: “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. Most real time qPCR-based assays target only two or three targets on the viral genome.”
MassARRAY SARS-CoV-2 Panel is a high throughput Covid-19 test
The authorisation is expected to address the material shortages and enable laboratories to accelerate testing regardless of instrument or reagent availability.
Also, the clinical laboratories will be able to process few thousands of samples per day, at a price of less than $10 per sample running the assay on a single MassARRAY instrument, said the company.
Agena Bioscience claimed that its new MassARRAY SARS-CoV-2 Panel is one of the few highest throughput SARS-CoV-2 tests, to receive FDA EUA.
The molecular diagnostics company is engaged in development, manufacturing and supplying genetic analysis systems and reagents.
Agena Bioscience technology and operations senior vice president Jason Halsey said: “The unique characteristics of the Agena detection technology provide significant supply chain advantages.
“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.”
