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FDA Grants EUA to KogeneBiotech, Trax Management, and Compass Laboratory Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests from by KogeneBiotech, Trax Management, and Compass Laboratory Services.

KogeneBiotech's PowerChek 2019-nCoV Real-time PCR Kit is designed to detect the SARS-CoV-2 RdRP and E genes in anterior/mid-turbinate nasal swabs, nasopharyngeal/oropharyngeal swabs, nasopharyngeal washes/aspirates or nasal aspirates, bronchoalveolar lavage, and sputum.

According to the South Korean company, nucleic acid extraction is performed using Qiagen's QIAamp DSP Viral RNA Mini Kit and the test runs on Thermo Fisher Scientific's Applied Biosystems 7500 or 7500 Fast RT-PCR instrument or Bio-Rad's CFX96 Real-time PCR Detection System.

Trax Management's PhoenixDx SARS-CoV-2 Multiplex is designed to detect the ORF1ab and N genes of the virus in upper respiratory and bronchoalveolar lavage specimens.

Nucleic acid is extracted using RTA Laboratories' RTA Viral Nucleic Acid Isolation Kit, Qiagen's QIAamp MinElute Virus Spin Kit, Roche's High Pure Viral RNA Kit, Thermo Fisher's MagMax Viral/Pathogen Nucleic Acid Isolation Kit, or Procomcure Biotech's SphaeraMag DNA/RNA Isolation Kit. It runs on the CFX96 instrument, Thermo Fisher's QuantStudio I RT-PCR System, Qiagen's Rotor-Gene Q, the Applied Biosystems 7500 Fast system, DNA-Technology's DTPrime RT-PCR Thermal Cycler, or Analytik Jena's qTower 3 RT-PCR Thermal Cycler.

The PhoenixDx SARS-CoV-2 Multiplex was developed by Thalgau, Austria-based Procomcure and is distributed in the US by Lewis Center, Ohio-based Trax. In April, Trax received EUA for Procomcure's PhoenixDx 2019-CoV test. 

The PowerChek and PhoenixDx SARS-CoV-2 Multiplex tests are authorized for use by any lab CLIA-certified to perform high-complexity tests, according to the FDA.

The Compass Laboratory Services SARS-CoV2 Assay is designed to detect the ORF1ab gene of the virus in upper respiratory specimens. It can be used with the Everlywell COVID-19 test home collection kit, which has EUA from the FDA, and runs on Thermo Fisher's QuantStudio 12K Flex and QuantStudio 7 Flex Quantitative RT-PCR instruments. Nucleic acid extraction is performed using the MagMax Viral/Pathogen Nucleic Acid Isolation Kit. 

The test may only be performed by Memphis, Tennessee-based Compass.