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FDA Grants Emergency Use Authorizations for Phosphorus Diagnostics, Genetron Coronavirus Tests

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Phosphorus Diagnostics and Genetron Health.

Phosphorus' COVID-19 RT-qPCR Test is designed to detect SARS-CoV-2 RNA in saliva specimens collected either by healthcare providers or a by patients at home using OraSure Technologies' DNA Genotek's Oragene Dx OGD-510 collection kit. Nucleic acid extraction is performed using Thermo Fisher Scientific's MagMax Viral/Pathogen Nucleic Acid Isolation Kit, or Promega's Maxwell HT or Maxwell RSC Viral Total Nucleic Acid Kits. The test runs on Bio-Rad's CFX384 Touch Real-Time PCR Detection System with CFX Manager software version 3.1.

Phosphorus' test may only be performed at the company's CLIA-certified laboratory. According to the New York City-based company, the test is the second to receive EUA from the FDA for use with self-collected saliva samples following the authorization of Rutgers University's RUCDR Infinite Biologics' SARS-CoV-2 test.

Genetron's SARS-CoV-2 RNA Test is designed to detect the virus' ORF1ab and N genes in upper respiratory specimens such as nasal swabs and runs on any authorized RT-PCR instrument. According to the Beijing-based company, the test, which received CE marking in April, has been approved for export by Chinese regulators.