LUXEMBOURG--(BUSINESS WIRE)--empowerDX, a Eurofins (Paris:ERF) subsidiary, announced the launch of its direct-to-consumer, FDA-emergency use authorised, 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-19 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 authorised 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.
This home-collection kit has not been FDA cleared or approved; rather it has been authorised 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 authorisation 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 authorisation is revoked sooner.
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