Thermo Fisher Scientific Increases Availability of COVID-19 Testing with Sample Collection Kit from Everlywell

Rhea-AI Summary

Thermo Fisher Scientific (NYSE:TMO) has expanded the Emergency Use Authorization (EUA) for its TaqPath COVID-19 Combo Kit to incorporate nasal swab specimens collected via Everlywell's COVID-19 Test Home Collection Kit. This partnership aims to enhance access to PCR-based testing, increasing convenience for individuals. With more than 10,000 employees participating in a pilot program for at-home testing, Thermo Fisher aims to bolster workplace safety as organizations seek to manage COVID-19 risks. Note that this home collection kit is authorized under an EUA and not FDA approved.

Positive

• Expansion of EUA for TaqPath COVID-19 Combo Kit to include Everlywell's home collection kit.
• Enhances access to COVID-19 testing, promoting workplace safety and confidence for return-to-work strategies.

Negative

• Home collection kit has not been FDA cleared or approved, potentially raising concerns about validation.

WALTHAM, Mass., Oct. 19, 2020 /PRNewswire/ -- Thermo Fisher Scientific Inc. (NYSE:TMO), 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."

For more information on the workplace testing program, please visit our website.

*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.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Media Contact Information:
Charlotte McCormack
Phone: 781-622-1202
Email: charlotte.mccormack@thermofisher.com

Investor Contact Information:
Ken Apicerno
Phone: 781-622-1294
Email: ken.apicerno@thermofisher.com

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SOURCE Thermo Fisher Scientific

FAQ

What is the significance of Thermo Fisher's EUA expansion for TMO?

Thermo Fisher expanded the EUA for its TaqPath COVID-19 Combo Kit to include home collection capabilities, enhancing testing access.

How does the partnership with Everlywell impact COVID-19 testing?

The collaboration with Everlywell allows for more convenient home nasal swab collection, increasing the efficiency of COVID-19 testing.

What financial metrics support Thermo Fisher's COVID-19 testing expansion?

Thermo Fisher's annual revenue exceeds $25 billion, indicating substantial resources for supporting COVID-19 initiatives.

Is the home collection kit from Everlywell FDA approved?

No, the Everlywell home collection kit has not been FDA cleared or approved but is authorized under an EUA.