Skip to main content
Premium Trial:

Request an Annual Quote

FDA Grants Emergency Use Authorizations for Wadsworth Center, Altru Dx Coronavirus Tests

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations (EUA) for SARS-CoV-2 assays developed by the New York State Department of Health's Wadsworth Center and Altru Diagnostics.

Wadsworth's New York SARS-CoV Microsphere Immunoassay for Antibody Detection is designed to detect human immunoglobulin G, immunoglobulin M, and immunoglobulin A antibodies against SARs-CoV-2 in serum. It runs on the Luminex FlexMap dual laser cytometer and is only authorized for use by Wadsworth.

Altru Diagnostics' SARS-CoV-2 Test uses Thermo Fisher Scientific's TaqMan 2019-nCoV Assay Kit v1 and is designed to detect the Orf1ab, N gene, and S gene regions of the SARS-CoV-2 RNA genome in upper respiratory specimens including nasal swabs. Nucleic acid extraction is performed using Thermo Fisher's KingFisher Flex Purification System with Applied Biosystems MagMax Viral/Pathogen Nucleic Acid Isolation Kit, and the test runs on Thermo Fisher's QuantStudio 12K Flex RT-PCR system with the QuantStudio 12K Flex Software V.1.2.2.

Use of the test is limited to Houston, Texas-based Altru Diagnostics.

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.