FRAMINGHAM, Mass., March 10, 2021 /PRNewswire/ -- empowerDX, part of the Eurofins Clinical Diagnostics network, announced the launch of its direct-to-consumer, FDA-emergency use authorized, COVID-19 Home Collection Kit on Amazon. The kits are available to consumers and businesses for purchase without a prescription, enabling greater access to COVID tests, to help the fight against the pandemic. 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 EUA authorized SARS-CoV-2 RT-PCR assay. That assay offers one of the best sensitivity rates of the 117 tests that have submitted results to the FDA SARS-CoV-2 Reference Panel1.
The empowerDX at-home test kit is available for $99 on Amazon.com. 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 kit is available as a single purchase and as a pack of 10. Orders placed Monday through Friday by 2 p.m. Eastern will ship for next day arrival.
Prior to taking the test, customers can easily activate their kits at empowerdxlab.com. Results are delivered securely to the customer's patient portal, typically within 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.
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.
ABOUT EMPOWERDX
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. Armed with an exclusive consortium of CLIA-certified and CDC-regulated clinical laboratories in the US, empowerDX is positioned to lead the market for cutting edge, self-collected diagnostic and non-diagnostic testing. All clinical tests are reviewed by their 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.
SOURCE empowerDX
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