Eurofins and Rite Aid Launch FDA Cleared Over-the-Counter COVID-19 Home PCR Test at All Rite Aid Locations in the United States
LUXEMBOURG – (COMMERCIAL THREAD) – Eurofins (Paris: ERF), via its subsidiary empowerDX, and Rite Aid announce the launch of an over-the-counter product approved by the FDA, Home COVID-19 PCR Test Kit. The co-branded kits, available at all Rite Aid stores in 17 states in the United States, will provide a convenient way for customers to test for the virus from their homes and detect the virus in symptomatic and asymptomatic patients.
COVID-19 Home Nasal PCR Kit is one of the first over-the-counter home test kits for SARS-CoV-2 to receive Emergency Use Authorization (EUA) from the Food and Drug United States Administration. The test was developed by Eurofins Viracor, one of the leading infectious disease testing laboratories, and is based on its SARS-CoV-2 RT-PCR test cleared by the FDA EUA. As of December 2020, this latest test offers one of the best sensitivity rates of the 117 laboratories that submitted results to the FDA 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 said: “We are excited to partner with Rite Aid and launch this COVID-19 Home Testing Kit, making access to testing kits widely available to people across the United States through Rite Aid’s National Network. Increasing the screening rates of the population is an important step in the fight against the pandemic and its new, more infectious variants, and in building the confidence necessary to accelerate a return to everyday life. ”
This home collection kit has not been authorized or approved by the FDA; instead, it has been authorized by the FDA under an EUA only for the home collection and maintenance of nasal swab specimens as an aid in the detection of SARS-CoV-2 nucleic acid, and not for other viruses or pathogens, and only for the duration of the declaration that there are circumstances justifying the authorization of the emergency use of medical devices under section 564 (b) (1) of the Federal Food, Drug and Cosmetic Act, 21 USC § 360bbb-3 (b) (1), unless the statement is terminated or the authorization is earlier revoked.
About Eurofins – the world leader in bio-analysis
Eurofins tests for life. With more than 50,000 employees in a network of more than 800 laboratories in more than 50 countries, Eurofins companies offer a portfolio of more than 200,000 analysis methods. Eurofins shares are listed on the Euronext Paris Stock Exchange.
empowerDX is the online store for easy home health testing. empowerDX specializes in FDA-cleared COVID-19 testing, women’s health, men’s health, sexual health, and general wellness testing.