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emergency use authorization approved

FDA Authorizes Mount Sinai Hospital’s COVID-19 Test for Emergency Use

September 1, 2021

The FDA has granted Emergency Use Authorization for a COVID-19 test developed by Mount Sinai Hospital’s Center for Clinical Laboratories in New York City.

The Mount Sinai SARS-CoV-2 assay works with saliva samples that can be collected at home using the hospital’s collection kit.

The FDA has only authorized the assay for use at the Mount Sinai COVID Laboratory, which was established earlier this year in collaboration with the nonprofit Pershing Square Foundation. The lab program enables students and staff members at New York City schools to get tested regularly as the city transitions back to in-person learning.

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