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Cepheid Gets FDA Emergency Use Authorization for US Department of Defense Coronavirus Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for an RT-PCR-based SARS-CoV-2 test developed by Cepheid for use by the US Department of Defense.

Cepheid's Xpert Xpress SARS-CoV-2 DoD test is designed to detect the N and E genes of the virus in upper respiratory specimens collected by healthcare providers. The test can be performed on Cepheid's automated GeneXpert Dx, GeneXpert Infinity, and GeneXpert Xpress systems and has been validated for use with pooled samples containing up to eight specimens.

Use of the test is limited to DoD-designated CLIA laboratories, according to the FDA.

Sunnyvale, California-based Cepheid previously received EUAs from the FDA for its Xpert Omni SARS-CoV-2 test and a multiplex SARS-CoV-2, influenza, and respiratory syncytial virus test.