Eurofins (Paris:ERF) subsidiary, empowerDX, today announced that it is working with Uber to offer FDA-emergency use authorized, at-home COVID-19 testing kits to consumers via on-demand delivery
Consumers in more than two dozen U.S. cities, including Tampa, Houston, Phoenix, Denver, Seattle, Minneapolis, Fort Lauderdale and Austin can order the kit directly from the empowerDX website without a prescription. empowerDX and Uber plan to expand test kit delivery to additional cities in the coming weeks.
The empowerDX at-home COVID-19 test can detect the virus in both symptomatic and asymptomatic patients. Eurofins Viracor, an infectious disease testing laboratory for more than 35 years, developed the empowerDX test based on its own FDA emergency-use authorized SARS-CoV-2 RT-PCR assay. As of December 2020, that assay offers one of the best sensitivity rates of the 117 laboratories that have submitted results to FDA’s SARS-CoV-2 Reference Panel.
The kit includes step-by-step instructions, a shallow nasal swab, test tube and a pre-paid FedEx package for easy sample returns.
This home collection kit has been authorized by the FDA under an Emergency Use Authorization; 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.
For more information on empowerDX, please visit empowerDXlab.com. For more information about how Uber partners with healthcare organizations to help reduce barriers to care, please visit uberhealth.com.
About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. With over 50,000 staff across a network of more than 800 laboratories in over 50 countries, Eurofins’ companies offer a portfolio of over 200,000 analytical methods.
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Source: Eurofins Scientific