Skip to main content
Premium Trial:

Request an Annual Quote

FDA Grants Emergency Use Authorization for Rize Laboratory qPCR COVID-19 Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Rize Laboratory's SARS nCoV-2019 Multiplexed Assay.

The reverse transcription qPCR assay is designed for the in vitro qualitative detection of RNA from SARS-CoV-2 in anterior nasal swab samples collected by a healthcare provider or self-collected under the supervision of a healthcare provider. The test may be used in people with or without COVID-19 symptoms.

The test targets sequences in the N1 and N2 genes of the SARS-CoV-2 virus and runs on Thermo Fisher Scientific's ABI 7500 Fast Thermocycler and KingFisher Flex sample prep instrument.

Use of the test is limited to Corvallis, Oregon-based Rize Laboratory, according to the FDA, which is certified under CLIA and meets the requirements to perform high complexity testing.

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.