Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Rise of BA.5

The New York Times reports that the Omicron subvariant BA.5 has become the dominant version of SARS-CoV-2 in the US.

UK Health Secretary Resigns

Sajid Javid, the UK health secretary, resigned along with Chancellor Rishi Sunak, saying they cannot work with Prime Minister Boris Johnson's government. CNN reports.

Clones From Freeze-Dried Cells

A team in Japan has cloned mice from freeze-dried skin cells, according to the Guardian.

Genome Research Papers on Craniosynostosis, Macaque Retrotransposition, More

In Genome Research this week: structural variants in craniosynostosis, LINE-1 activity in rhesus macaque brain, and more.