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Diagnostic Solutions Laboratory, MD Anderson Coronavirus Tests Get FDA Emergency Use Authorizations

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Diagnostic Solutions Laboratory and the University of Texas MD Anderson Cancer Center.

Diagnostic Solutions' DSL COVID-19 assay is designed to detect the SARS-CoV-2 nucleocapsid (N) and spike genes in upper respiratory specimens, such as nasal swabs, and bronchioalveolar lavage. It uses Thermo Fisher Scientific's KingFisher nucleic acid extraction instrument with Omega Bio-Tek's MagBind Viral DNA/RNA 96 Kit extraction reagents and runs on Thermo Fisher's Applied Biosystems QuantStudio 5 Real-Time PCR system.

The MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay detects two targets in the virus' N gene in upper respiratory specimens. It uses Hamilton Robotics' MicroLab Starlet automated liquid handler for RNA extraction and PCR reagent preparation, and runs on either the QuantStudio 7 Fast Flex RT-PCR system, the Applied Biosystems 7500 RT-PCR system, or the QuantStudio Dx RT-PCR system with 96-well fast block.

Both tests may only be performed by their developers, according to the FDA.