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Solaris Diagnostics, Alpha Genomix Coronavirus Tests Get FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Solaris Diagnostics and Alpha Genomix Laboratories.

The Solaris Multiplex SARS-CoV-2 Assay is designed to detect the N gene of the virus in nasopharyngeal, anterior nasal, mid-turbinate nasal, and oropharyngeal swabs, as well as nasopharyngeal wash/aspirates, nasal aspirates, and bronchoalveolar lavage specimens. RNA extraction is performed using Thermo Fisher Scientific's MagMAX Viral/Pathogen Ultra Nucleic Acid Isolation Kit on that company's KingFisher Flex extraction instrument, and the test runs on Thermo Fisher's Applied Biosystems QuantStudio 5 Real-Time PCR System.

The test may be performed only by Nicholasville, Kentucky-based Solaris, the FDA said.

The Alpha Genomix TaqPath SARS-CoV-2 Combo Assay is based on Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, which received a second expanded EUA in March, and is designed to detect the virus' ORF1ab, N, and S genes in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swab specimens. It uses the Roche MagNA Pure 96 instrument for automated nucleic acid extraction and runs on the Applied Biosystems QuantStudio 12K Flex RT-PCR System. 

The test may be performed only by Peachtree Corners, Georgia-based Alpha Genomix, according to the FDA.