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FDA Issues Emergency Use Authorization for UCLA NGS-Based SARS-CoV-2 Test

NEW YORK – The US Food and Drug Administration on Tuesday issued Emergency Use Authorization to UCLA's SwabSeq COVID-19 Diagnostic Platform for detecting SARS-CoV-2.

The device is for the qualitative detection of the coronavirus in nasopharyngeal swabs, oropharyngeal swabs, mid-turbinate nasal swabs, and anterior nasal swabs from individuals who are suspected of having COVID-19, the disease caused by SARS-CoV-2.

According to the FDA's authorization letter, the UCLA SwabSeq COVID-19 Diagnostic Platform is a next-generation sequencing-based in vitro diagnostic test and is intended for use by lab personnel trained to use Illumina's MiSeq and NextSeq systems. RNA extraction is performed using Thermo Fisher Scientific's Kingfisher instrument and the company's MagMax Viral/Pathogen Nucleic Acid Isolation kit. Reverse transcription and targeted PCR amplification is performed using Thermo Fisher's TaqPath 1-step RT-qPCR Master Mix with the Veriti 384-well thermal cycler. 

Testing with the platform can be done only at the UCLA Clinical Microbiology Laboratory.