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DxTerity, Texas Department of State Health Services Coronavirus Molecular Tests Get FDA EUAs

NEW YORK — The US Food and Drug Administration on Friday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by DxTerity Diagnostics and the Texas Department of State Health Services (DSHS).

The DxTerity SARS-CoV-2 RT-PCR Test is designed to detect the virus' N, S, and ORF1ab genes in saliva specimens. RNA extraction is performed using Thermo Fisher Scientific's Applied Biosystems MagMax 96 Magnetic Particle Processor and the test runs on the Applied Biosystems ViiA 7 Real-Time PCR System.

DxTerity's test, which uses primers and probes developed and validated under the Emergency Use Authorization for Thermo Fisher's Applied Biosystems TaqPath COVID-19 Combo Kit, can be used by any lab CLIA-certified to perform high-complexity testing.

The Texas DSHS SARS-CoV-2 Assay is designed to detect the N and ORF1ab genes of the virus in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, as well as nasal aspirates, nasal washes, and bronchoalveolar lavage fluid specimens.

The test uses PerkinElmer's Chemagic 360 instrument for nucleic acid purification and runs on Thermo Fisher's Applied Biosystems 7500 Fast Dx Real-Time PCR System. PerkinElmer's Janus G3 Automated Workstation may also be used for sample preparation.

The Texas DSHS test may be used by any lab CLIA-certified to perform high-complexity testing, the FDA said.

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