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Ambry Genetics Gets FDA Emergency Use Authorization for Coronavirus Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a PCR-based SARS-CoV-2 saliva test developed by Ambry Genetics.

The Ambry COVID-19 RT-PCR Test is designed to detect the ORF1ab, N, and S genes of the virus in saliva specimens collected in a healthcare setting using Orasure Technologies' DNA Genotek's FDA-authorized OMNIgene·ORAL OM-505 or OME-505 saliva collection devices. Saliva samples may also be self-collected at home using the company's Ambry COVID-19 RT-PCR Test Saliva Collection Kit.

The test uses primers and probes from Thermo Fisher Scientific's FDA-authorized TaqPath COVID-19 Combo Kit with a modified results interpretation algorithm and runs on that company's Applied Biosystems 7500 Fast Dx instrument. 

The test may be performed only by Aliso Viejo, California-based Ambry, which is part of Konica Minolta, according to the FDA.