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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

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

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Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.