LUXEMBOURG–(BUSINESS WIRE)–Eurofins’s Clinical Enterprise, Inc. announces that 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 Panel1.
Eurofins’ CEO, Gilles Martin commented: “This product has the potential to significantly increase population testing rates and help build confidence to accelerate the return of everyday life. We are also working very closely with European authorities for the approval of similar direct-to-consumer products.”
This home-collection kit has not been FDA cleared or approved; rather it has been authorized by FDA under an EUA only for the home collection and maintenance of nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens, and only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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