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5th March 2021  Product update: rapidvirology staff writer

US FDA Authorize Direct-to-Consumer COVID-19 PCR Test


Eurofins’s Clinical Enterprise, Inc. has announced it has received US Food and Drug Administration Emergency Use Authorization (EUA) for a direct-to-consumer (DTC) version of its EmpowerDX COVID-19 Home Collection Kit.

The Eurofins at-home COVID-19 nasal PCR kit is among the first over-the-counter at-home test kits for SARS-CoV-2 to receive EUA. With this authorization, Eurofins is able to sell the test kit directly to consumers without prescription.

The kit is currently available through Eurofins’ subsidiary, empowerDX. The at-home test kits can be easily ordered online for $99 at empowerdxlab.com, and are also available in pharmacies across the U.S.

The at-home COVID-19 test kit includes step-by-step instructions, a shallow nasal swab, test tube and a pre-paid FedEx package for the easy return of samples.  Customers will receive their results to a secure patient portal within 48 hours.

This test was developed by Eurofins Viracor, a leading infectious disease testing laboratory, and is based on its FDA EUA authorized SARS-CoV-2 RT-PCR assay. That assay is ranked one of the most sensitive of the 117 tests evaluated by the FDA SARS-CoV-2 Reference Panel.  

Reference: 

1. SARS-CoV-2 Reference Panel Comparative Data


    

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Date Published: 5th March 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.


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