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FDA Grants Emergency Use Authorization for Genetrack Biolabs SARS-CoV-2 Molecular Assay

NEW YORK ─ The US Food and Drug Administration has granted Emergency Use Authorization for the Genetrack SARS-CoV-2 Molecular Assay developed by Seattle-based Genetrack Biolabs.

The PCR-based assay is used for the detection of SARS-CoV-2 RNA in anterior nasal swab specimens self-collected at home using the Vo' COVID-19 Test Home Collection Kit. It is designed for people suspected of COVID-19 for whom a healthcare provider has determined that sample self-collection is appropriate.

Specimens collected using the Vo’ COVID-19 Test Home Collection Kit are transported at ambient temperature for testing at Genetrack Biolabs' laboratory in Vancouver, British Columbia.

SARS-CoV-2 nucleic acid is extracted from the specimens and reverse transcribed into cDNA, followed by PCR amplification and detection using an authorized RT-PCR instrument. The test can currently be used with Thermo Fisher's Applied Biosystems QuantStudio 6 Pro Real-Time PCR System with software v2.4.1.