Eurofins launches a rapid SARS-CoV-2 antigen test and a RT-PCR test in a self-sampled, gargling format

Eurofins Technologies announces the launch of two important products to support the fight against COVID-19:

• a CE-IVD labelled rapid test for the detection of SARS-CoV-2 antigens in 15 minutes; and
• a SARS-CoV-2 RT-PCR test that has been successfully validated for pharynx gargling samples, providing a gold standard PCR test in an easy-to-use, self-sampling format especially beneficial in the testing of children.

The GSD NovaGen SARS-CoV-2 (COVID-19) antigen rapid test provides results from nasopharyngeal samples within 15 minutes. With diagnostic sensitivity of 92.6% and diagnostic specificity of 98.6%, the test meets WHO performance criteria (sensitivity ≥80%; specificity ≥97%) for use in the global fight against COVID-19.

The GSD NovaPrime® SARS-CoV-2 (COVID-19) is a highly sensitive Multiplex Real-Time PCR test for the direct qualitative pathogen detection of SARS-CoV-2. The assay simultaneously detects two target sequences in the N gene. The multiplex PCR test allows for a streamlined workflow in one reaction and provides results in approximately one hour. Since the launch of the product in May, more than five million tests have been performed on validated sample types. The GSD NovaPrime® SARS-CoV-2 (COVID-19) has now been successfully validated for pharynx gargling samples. In contrast to nasopharyngeal swabs, gargling is a non-invasive, easy-to-use sampling method that is less uncomfortable for the patient and particularly useful for self-sampling applications and the testing of children.

These two kits can also be purchased online by appropriately licensed practitioners at the Eurofins Technologies webshop and are for use only where officially authorized in Europe. Eurofins Technologies intends to separately file FDA EUA applications for the new testing modalities.

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

Notes for the editor:

About Eurofins Technologies

Building on the experience and scientific excellence of the Eurofins Group, Eurofins Technologies is a fast growing global provider of diagnostic technologies and industry-leading ELISA-based instruments in the field of bioanalytical testing for the food, feed, environmental, animal health, and clinical diagnostics industries.

Its R&D teams located at various sites around the world share their expertise in developing a wide range of innovative methods and applications with a focus on immunoassays and molecular testing. For further information, please visit the Eurofins Technologies website.

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.

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