Eurofins U.S. Clinical Diagnostics Network Receives EUA Approval of At Home COVID-19 Test At Home COVID-19 Nasal PCR Test is easy to use and painless

Eurofins U.S. Clinical Diagnostics, announced that Clinical Enterprise Inc. has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for their At Home COVID-19 Nasal PCR Test. The EUA authorized self-collection kit gives consumers a minimally invasive, convenient and quick option to test from the comfort of their home. Results are reviewed by a licensed physician and provided via email within 24 hours of sample receipt.

Available through the Eurofins direct-to-consumer company, empowerDX, the at home test can be easily ordered online (https://empowerdxlab.com/) for $89. After completing a simple online questionnaire, consumers will receive the sample collection kit via FedEx. The user-friendly kit includes a small nasal swab, collection tube, easy to follow step-by-step instructions and a pre-paid, pre-addressed FedEx package. The nasal swabs for the empowerDX at Home COVID-19 Test are a less invasive alternative than more common nasal pharyngeal swabbing techniques.

Eurofins’ infectious disease centre for excellence, Viracor, developed the test based on its highly sensitive, FDA EUA-authorized SARS-CoV-2 RT-PCR assay.

The Eurofins U.S. Clinical Diagnostics network has been at the forefront of COVID-19 testing – launching its first RT-PCR (real-time reverse-transcriptase polymerase chain reaction) assay for SARS-CoV-2 on March 13. Since then, Eurofins has rolled out several highly sensitive and specific, active infection and antibody assays to thousands of clients nationwide, including hospitals, physicians’ offices, nursing homes, government entities, sports organizations and employers. At-home COVID-19 testing adds an additional capability to an already robust group of assays including pooled testing, antibody testing, wastewater, used-mask, and soon to be launched saliva testing.

Concurrent to ongoing COVID-19 assay innovation, Eurofins has increased capacity throughout its network of labs to ensure sufficient capacity is available to ensure consistency of turnaround time should COVID-19 infections continue to increase in the upcoming weeks. Since March, Eurofins US Clinical Diagnostics testing capacity has ramped up to over 500,000 samples per week. The turnaround time for results has averaged less than18 hours from receipt in the lab.

The At Home COVID-19 Nasal PCR Test is currently not available in New York, New Jersey, Rhode Island, and Maryland.

This home-collection kit has not been FDA cleared or approved; rather it has been authorized by FDA under an EUA only for the self-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 in medical devices during the COVID-19 outbreak under Section 64(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Notes to Editors:

For more information, please visit www.eurofins.com or contact:

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. Armed with an exclusive consortium of CLIA-certified and CDC-regulated clinical laboratories in the US, empowerDX is positioned to lead the market for cutting edge, self-collected diagnostic and non-diagnostic testing. All clinical tests are reviewed by their licensed ordering physician to eliminate the need for a phlebotomist or a telemedicine-observed sample collection. Welcome to health clarity with just a few clicks. The company is based outside of Boston, in Framingham, MA. To learn more, please visit empowerdxlab.com.

About Eurofins – the global leader in bio-analysis

Eurofins Scientific, through its subsidiaries (hereinafter “Eurofins” or “the Group”), believes it is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing. With over 48,000 staff across a network of more than 900 independent companies in over 50 countries generally specialised by end client markets and operating more than 800 laboratories, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of a wide range of products, as well as providing innovative clinical diagnostic testing services. The Group’s objective is to provide its customers with high-quality and innovative services, accurate results on time and, when requested, expert advice by its highly-qualified staff.

Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions and a very large range of testing methods.

As one of the most innovative and quality-oriented international groups in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world.

Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).

Important disclaimer:

This press release contains forward-looking statements and estimates that involve risks and uncertainties. The forward-looking statements and estimates contained herein represent the judgment of Eurofins Scientific’s management as of the date of this release. These forward-looking statements are not guarantees for future performance, and the forward-looking events discussed in this release may not occur. Eurofins Scientific disclaims any intent or obligation to update any of these forward-looking statements and estimates. All statements and estimates are made based on the information available to the Company’s management as of the date of publication, but no guarantees can be made as to their completeness or validity.

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