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Boston University, Cepheid Get FDA EUAs for COVID-19, Monkeypox Tests

NEW YORK – The HFI Laboratory at Boston University and Danaher subsidiary Cepheid received Emergency Use Authorizations from the US Food and Drug Administration last week for SARS-CoV-2 and monkeypox tests, respectively. 

The HFI Lab, doing business as the BU Clinical Testing Laboratory, received EUA for its high-throughput real-time quantitative RT-PCR test to qualitatively detect SARS-CoV-2 from anterior nares swab specimens. Use of the test is limited to the HFI Laboratory, according to the authorization document from the FDA. 

Cepheid's PCR-based test qualitatively detects DNA from monkeypox virus clade II and non-variola Orthopoxvirus from human lesion swab specimens, the FDA's authorization document said. It runs on the company's GeneXpert line of instruments, including the GeneXpert Dx and GeneXpert Infinity platforms within moderate- and high-complexity labs and the GeneXpert Xpress in point-of-care settings.