On Oct. 19, 2020, Thermo Fisher Scientific announced it had received an expansion of its Emergency Use Authorization for the TaqPath COVID-19 Combo Kit to include an additional sample collection method provided by Everlywell, a leading digital health testing company. The TaqPath test is 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.

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. This more convenient home-collection sample processing experience is expected to increase access to highly accurate PCR-based testing and complement other defensive measures including good hygiene, social distancing and wearing a mask.

This home collection kit has not been FDA cleared or approved.It has been authorized by the FDA under an EUA for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This home collection kit in combination with the authorized test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use.