Eurofins & Rite Aid Launch an Over-the-Counter, FDA-Authorised, at-Home COVID-19 PCR Test in all Rite Aid Locations in the U.S.
09 Juillet 2021 - 2:00PM
Business Wire
Eurofins (Paris:ERF), through its empowerDX subsidiary, and Rite
Aid announce the launch of an over-the-counter, FDA-authorised[1],
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.”
[1]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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210709005186/en/
Annemarie Watson ir@eurofins.com
Eurofins Scientific (EU:ERF)
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