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DxTerity Diagnostics, Patients Choice Get FDA Emergency Use Authorizations for Coronavirus Tests

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for molecular SARS-CoV-2 tests developed by DxTerity Diagnostics and Patients Choice Laboratories.

The DxTerity SARS-CoV-2 RT-PCR CE Test is an endpoint RT-PCR-based test followed by detection with capillary electrophoresis. It is designed to detect the virus' N, E, and ORF1ab genes in saliva specimens self-collected using Spectrum Solutions' SDNA-1000 Saliva Collection Device.

Nucleic acid extraction is performed using GE Healthcare's Sera-Mag SpeedBeads Carboxyl Magnetic Beads with Thermo Fisher Scientific's Applied Biosystem MagMax 96 Magnetic Particle Processor. The test runs on Thermo Fisher's Veriti Dx Thermal Cycler and Applied Biosystems 3500xL Dx Genetic Analyzer.

The test may be performed only by Rancho Dominguez, California-based DxTerity, which received EUA from the FDA last month for the DxTerity SARS-CoV-2 RT-PCR Test. 

Patients Choice's PCL SARS-CoV-2 Real-Time RT-PCR assay is designed to detect the N, ORF1ab, and S genes of the virus in nasopharyngeal and oropharyngeal swab specimens. It is a version of Thermo Fisher's authorized TaqPath COVID-19 Combo Kit that has been modified to allow processing on 384-well plates and to run on the Applied Biosystems QuantStudio 12K Flex instrument. Nucleic acid extraction is performed using Hamilton's automated Microlab Vantage Liquid Handling System and Omega Biotek's Mag-Bind Viral RNA Xpress Kit. 

The test may be performed only by Indianapolis-based Patients Choice.