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FDA Reissues Emergency Use Authorization for Thermo Fisher Scientific COVID-19 Combo Kit

NEW YORK ─ The US Food and Drug Administration on Friday reissued an Emergency Use Authorization for the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit and expanded it to include an additional sample collection kit provided by Austin, Texas-based Everlywell as well as a new workflow.

In March, Thermo Fisher's test was the second commercial diagnostic assay to be granted EUA.

The TaqPath test is now authorized for use with the Everlywell COVID-19 Test Home Collection Kit, which enables individuals to self-collect nasal swab specimens when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire, Waltham, Massachusetts-based Thermo Fisher said in a statement.

Samples collected using the Everlywell self-collection kit may be processed by CLIA-certified laboratories running Thermo Fisher's TaqMan SARS-CoV-2 RNase P Assay Kit, and the results obtained through the Everlywell online platform, Thermo Fisher said. More convenient home-collection sample processing is expected to increase access to PCR-based testing and complement other defensive measures including good hygiene, social distancing, and wearing a mask, the firm added.

The FDA said that it further revised the EUA to add a workflow with increased purified RNA input volume.

Everlywell received EUA for its COVID-19 Test Home Collection Kit in May.