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FDA Grants Emergency Use Authorization for Eli Lilly, Sandia National Labs Coronavirus PCR Tests

NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Eli Lilly and Sandia National Laboratories.

The Lilly SARS-CoV-2 Assay is designed to detect the virus' nucleocapsid gene in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate swabs, as well as nasal aspirates, nasal washes, and bronchoalveolar lavage fluid. Nucleic acid is purified using Qiagen's QIAcube HT, and the test runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 7 Flex, Applied Biosystems QuantStudio Dx, or Applied Biosystems QuantStudio 12K Flex RT-PCR systems.

The test may be performed only by Indianapolis-based Eli Lilly, according to the FDA.

Sandia's SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic assay is designed to detect the SARS-CoV-2 nucleocapsid gene in upper respiratory and bronchoalveolar lavage specimens. RNA is isolated using Zymo Research's Quick-RNA Viral Kit, and the test runs on Thermo Fisher's Applied Biosystems 7500 or Applied Biosystems Quant Studio 5 systems or on Bio-Rad's CFX Connect or CFX96 instruments.

Use of the test is limited to Livermore, California-based Sandia, the FDA said.