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Agena Bioscience Gets FDA Emergency Use Authorization for MassArray Coronavirus Test

NEW YORK — Agena Bioscience on Monday received Emergency Use Authorization from the US Food and Drug Administration for its MassArray SARS-CoV-2 Panel.

The RT-PCR/MALDI-TOF test comprises five assays designed to detect the N, ORF1, and ORF1ab regions of the SARS-CoV-2 genome in upper respiratory specimens such as nasopharyngeal and oropharyngeal swabs, as well as bronchoalveolar lavage specimens.

RNA extraction is performed using Thermo Fisher Scientific's KingFisher Flex Purification System with Omega Bio-Tek's Mag-Bind Viral RNA Xpress Kit. Following PCR amplification on an authorized RT-PCR instrument, a sequence-specific primer extension step is performed using Agena's iPlex Pro reagents. Extension products are then transferred to Agena's SpectroChip Array for analysis on the company's MassArray mass spectrometry analyzer.

The test may be used by any lab CLIA-certified to perform high-complexity tests, according to the FDA.

"Agena proactively sourced and secured materials to provide uninterrupted product availability to our customers," Jason Halsey, Agena's senior VP of technology and operations, said in a statement. The "MassArray SARS-CoV-2 Panel kits and instruments are ready for immediate deployment, and we are equipped to supply millions of tests each month."

San Diego-based Agena said that thousands of samples can be processed in a day for less than $10 apiece on the MassArray instrument.

In addition to Agena's test, the MassArray system is used with authorized SARS-CoV-2 tests from the National Jewish Health Advanced Diagnostics Laboratory and Ethos Laboratories