Thermo Fisher Scientific, the world leader in serving science, announced it has received an expansion of its Emergency Use Authorization (EUA) 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.
“As part of our commitment to keep our workplaces safe and healthy, Thermo Fisher launched its own pilot program to provide at-home collection kits and online access to test results for more than 10,000 colleagues across the country,” said Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific.
“Now, leveraging Everlywell’s capabilities, we can expand our own use and offer other organizations the confidence to move forward with return-to-workplace strategies that reduce the risk of spreading the virus.”
Julia Cheek, chief executive officer and founder of Everlywell, said, “Everlywell is a leader in at-home collection laboratory testing, providing access to dozens of essential lab tests through our digital platform. Joining forces with Thermo Fisher, one of the world’s foremost life sciences and diagnostic companies, will expand our COVID-19 testing infrastructure and help keep workplaces, schools, and organizations safe over the coming months.”
She added, “Accurate, convenient diagnostic testing is foundational to our country’s efforts to reduce the spread of the virus. We are proud to support Thermo Fisher in these efforts.”
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.
Source: Company Press Release
