LUXEMBOURG– Clinical Enterprise Inc., d/b/a empowerDX, a Eurofins Scientific (Paris:ERF) company, announces its at-home COVID-19 testing kit has received FDA-emergency use authorization for children three years and older. The direct-to-consumer company is the first to receive an EUA for an at-home nasal PCR test for young children. empowerDX launched its FDA-authorized at-home COVID test in Q3 of 2020 to consumers 18 years and older. The company’s tests are now available without a prescription on empowerdxlab.com, Amazon, RiteAid as well as via Uber’s on-demand delivery service.
Easy, convenient, and painless testing options for children remain a crucial part of monitoring and slowing the spread of the virus – especially for those kids attending schools, summer camps, and indoor sports facilities.
The empowerDX test is one of the most sensitive at-home COVID tests on the market [1]. 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.
The Eurofins U.S. Clinical Diagnostics group of companies 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, as well as environmental monitoring assays, such as wastewater, air, and saliva tests.
This at-home testing kit not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization; it has been authorized 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.
