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FDA Grants Emergency Use Authorizations for Altona, Diatherix Eurofins Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Wednesday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Altona Diagnostics and Diatherix Eurofins.

Altona's RealStar SARS-CoV-2 RT-PCR Kit US is designed to detect viral nucleic acid in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, and nasal aspirates. It runs on any authorized RT-PCR instrument and may be performed by labs CLIA-certified for high-complexity testing.

Diatherix's SARS-CoV-2 Assay is designed to detect viral nucleic acid in nasal swabs, nasopharyngeal swabs/wash, oropharyngeal swabs/throat swabs, bronchial aspirates, or sputum. It has been validated for use with Thermo Fisher Scientific's KingFisher Flex System using either Qiagen's ClearMag or Omega Bio-tek's Mag-Bind extraction reagents. The test can also be performed on the Thermo Fisher's Applied Biosystems GeneAmp 9700 or Veriti 96-well Thermal Cycler, the FDA said.

Diatherix's test may only be performed by its own laboratory.

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