LUXEMBOURG--(BUSINESS WIRE)--Eurofins (Paris:ERF), through its empowerDX subsidiary, and Rite Aid announce the launch of an over-the-counter, FDA-authorised, at-home COVID-19 PCR Test Kit. The co-branded kits, available at all Rite Aid stores across 17 states in the USA, will offer customers a convenient way to test for the virus from their home and will detect the virus in symptomatic and asymptomatic patients.
The at-home COVID-19 nasal PCR kit is among the first over-the-counter at-home test kits for SARS-CoV-2 to receive US Food and Drug Administration Emergency Use Authorization (EUA). The test was developed by Eurofins Viracor, a leading infectious disease testing laboratory, and is based on its FDA EUA authorised SARS-CoV-2 RT-PCR assay. As of December 2020, this later assay offers one of the best sensitivity rates of 117 laboratories that have submitted results to the FDA’s SARS-CoV-2 Reference Panel; https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data#results.
Eurofins’ CEO, Gilles Martin commented: "We are excited to partner with Rite Aid and launch this at-home COVID-19 testing kit, making access to test kits widely available to people across the U.S through Rite Aid’s national network. Increasing population testing rates is an important step in fighting the pandemic, and its new more infectious variants, and building the confidence needed to accelerate a return to everyday life.”
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 authorization is revoked sooner.
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.Eurofins Shares are listed on Euronext Paris Stock Exchange.
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.