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

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.