FRAMINGHAM, Mass. and SAN FRANCISCO, April 26, 2021 /PRNewswire/ -- Clinical Enterprise, Inc. d/b/a empowerDX, part of the Eurofins Clinical Diagnostics group of companies, today announced that it is working with Uber (NYSE: UBER) to offer FDA-emergency use authorized, at-home COVID-19 testing kits to consumers via on-demand delivery. Individuals can now quickly access one of the most sensitive at-home COVID tests on the market1 – whether they are at home, in the office or traveling.
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 empowerDX at-home test kit is 100% covered by most insurance carriers. The kit includes step-by-step instructions, a shallow nasal swab, test tube and a pre-paid FedEx package for easy sample returns. The empowerDX at-home test is available for delivery Monday through Friday from 8 a.m. to 4 p.m.
Prior to taking the test, consumers can easily activate their kits online. Results are delivered securely to a secure patient portal, within an average of 24-hours from sample receipt at the company's CLIA-certified laboratory.
The Eurofins U.S. Clinical Diagnostics network has been at the forefront of COVID-19 testing – launching its first RT-PCR assay for SARS-CoV-2 on March 13, 2020. The Eurofins' SARS-CoV-2 assay menu now includes diagnostic tests, such as SARS-CoV-2 PCR and SARS-CoV-2 Plus Profiles (to detect Influenza and RSV), as well as environmental monitoring assays, such as wastewater, worn-mask, air, and saliva tests.
From helping remove transportation barriers so that people can get to vaccine appointments, to joining forces with innovative companies like Eurofins, Uber is committed to using its platform to address public health challenges head-on during the pandemic.
"Access to care has been a key social determinant of health for years and years, and the pandemic has augmented this issue," said Lauren Steingold Makler, Head of Strategic Initiatives at Uber Health. "Being able to access reliable COVID-19 tests is certainly an important piece of a larger public health challenge. That's why we're proud to work with empowerDX and the larger Eurofins Clinical Diagnostics Network team to help create easy access to critical testing for our communities and vulnerable populations."
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.
empowerDX is the online shop for easy at-home health testing. empowerDX specializes in FDA-authorized COVID-19 testing, women's health, men's health, sexual health and general wellness testing. Along with its affiliated CLIA-certified clinical laboratories in the U.S., empowerDX is positioned to lead the market for cutting edge, self-collected diagnostic and non-diagnostic testing. All clinical tests are reviewed by empowerDX's licensed ordering physician to eliminate the need for a phlebotomist or a telemedicine-observed sample collection. Welcome to health clarity with just a few clicks. The company is based outside of Boston, in Framingham, MA. To learn more, please visit empowerdxlab.com.
Uber's mission is to create opportunity through movement. We started in 2010 to solve a simple problem: how do you get access to a ride at the touch of a button? More than 15 billion trips later, we're building products to get people closer to where they want to be. By changing how people, food, and things move through cities, Uber is a platform that opens up the world to new possibilities.
1As of December 2020, our lab's SARS-CoV-2 assay offers the best sensitivity of the 117 laboratories that have submitted results to FDA's SARS-CoV-2 Reference Panel, with a limit of detection (LoD) of 180 NAAT Detectable Units/mL1. Source:https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data#results