Eurofins Launches COVID-19 PCR Tests With At-Home Self-Sampling Options in Europe and Donates Sequencing Capacity to Identify VUI-2020-12/01 Strain Reported to Spread Faster in the UK

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LUXEMBOURG–(BUSINESS WIRE)–
Regulatory News:

On 19 October 2020 Eurofins (Paris: ERF) launched EmpowerDX SARS CoV 2 RT PCR test with at-home sampling option after it received an Emergency Use Authorization (EUA) by the FDA. Demand for the testing kit available at empowerdxlab.com is increasing significantly week on week.

To make patient sampling easier by non-healthcare professionals and especially for testing children, Eurofins validated a sampling method based on gargling with a sterile solution. At-home gargling self-sampling offers the advantage of a simple non-invasive sampling method, allowing patients to be tested without any constraint of medical sampling capacity.

In Germany the EmpowerDx kit for the detection of SARS-CoV-2 is now available for order at www.empowerdx.eu and via the GeLaMed app available in the Apple webstore. In Spain the kit working on saliva is available at www.empowerdx.es and www.eurofins-megalab.com/producto/test-pcr-en-saliva. The kit is delivered to the patient and collected after self-sampling, with results delivered in less than 24 hours.

As this product can significantly expand access to testing, Eurofins will apply for regulatory approval to launch similar tests in the United Kingdom, France, Belgium, Netherlands and Sweden, amongst others.

A version of this product is derived from a test developed by Eurofins Viracor in March 2020 which was ranked by the FDA as the most sensitive out of more than 115 kits evaluated with the FDA reference panel evaluation (https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data#table2c).

These tests will also detect VUI2020-12/01 virus variants recently reported to be spreading quickly in the UK. Eurofins Genomics also has significant sequencing capacity to identify this or other variants of the virus (www.eurofins.com/media-centre/press-releases/2020-04-16).

Given the limited understanding of the prevalence of this new variant in Europe and the consequent potential pandemic acceleration, Eurofins has decided to donate part of its sequencing capacity to national public health authorities who do not have already approved funding to identify VUI2020-12/01 in their positive samples to evaluate local prevalence of this new strain. This knowledge may be useful in deciding on local isolation and travel restrictions.

Notes for the editor:

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 50,000 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 FR0014000MR3, Reuters EUFI.PA, Bloomberg ERF FP).

Until it has been lawfully made public widely by Eurofins through approved distribution channels, this document contains inside information for the purpose of Regulation (EU) 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse, as amended.

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.