Eurofins Technologies launches multiple CE-IVD marked serologic products for the detection of antibodies in patients who have been exposed to SARS-CoV-2 (COVID-19)
Friday, April 17, 2020
In a continued effort to help fight the COVID-19 crisis, Eurofins Technologies announces the CE-IVD marking of a first range of testing kits for serology-based antibody detection by ELISA of patients who have been exposed to COVID-19. The development of the assays has been spearheaded by affiliate companies Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH, NovaTec Immundiagnostica GmbH and Ingenasa (Inmunologia Y Genetica Aplicada SA). Those specialized diagnostic technologies companies are well-established providers of testing solutions with a strong focus on scientific excellence in infectious diseases testing and immunology.
According to experts, there is a large range of applications for serologic testing. Serology can be used to complement the PCR swab testing that detects the virus to help diagnose acute infections status and its evolution. It can help estimate the timing of infection. As knowledge develops about the immunity to potential reinfection of patients having previously contracted COVID-19 and recovered, antibodies testing may provide information about statistically reduced contagion risks of and from these persons. It could help identify donors of plasma from recovered patients that can be transfused into COVID-19 patients as a potential treatment. Long-term, serologic tools can contribute to discriminating between vaccine-induced antibodies and natural infection. As the pandemic unfolds, serosurveys can enable tracking closely what percentage of the population has become infected in each city or region. Serosurveys may also help efforts to develop vaccines and therapies.
The novel antibody tests for IgG, IgM, and IgA are intended for the qualitative detection of IgG, IgA and IgM antibodies to SARS-CoV-2 virus in human serum to aid in the identification of persons having been exposed to SARS-CoV-2, the virus causing COVID-19. Initial testing on more than 200 healthy and potentially cross reacting samples, demonstrated a very high specificity. These tests can be used to provide valuable information on individual patients as well as larger cohorts. The assays are compatible with many open high-throughput automation platforms and can therefore provide important cost-efficient testing capacity at scale.
As the understanding of the virus and the associated immune response will improve over the next weeks, Eurofins Technologies scientific experts will continue to work on the development of additional serological tests.
“This launch is the result of the strong devotion of our scientists to our fight against COVID-19. They worked round the clock over the last six weeks to develop and optimise tests with very high specificity. This is important in order to minimise risks of false positive detections. We are very pleased to provide this additional testing option in a time when many governments around the world are considering suitable step-wise paths out of their lockdowns. Better understanding the epidemiology and spread of the virus is an important element in the fight against this pandemic. Eurofins Technologies companies will immediately start shipments in significant quantities and we will at the same time offer these tests as a service in Eurofins clinical laboratories around the world. Our four factories and partners are ramping up to produce kits to carry out over 10 million tests per month” commented Dr. Gilles Martin, Chief Executive Officer.
For more information on the solutions, please visit: www.goldstandarddiagnostics.com
For more information, please visit www.eurofins.com or contact:
Phone: +32 2 766 1620
Notes for the editor:
About Eurofins Technologies – a fast growing provider of diagnostic technologies in the field of immunoassays and molecular detection methods
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 Genomics – a global leader in DNA sequencing services, next generation sequencing services, genotyping services, DNA synthesis products and bioinformatics services
Eurofins Genomics, a member of the Eurofins Group with facilities in Europe, the United States and Asia, is an internationally leading provider of DNA sequencing services, next generation sequencing services, genotyping services, DNA synthesis products and bioinformatics services for pharma, diagnostics, food, agriculture, biotechnological and research markets. The company's strength is its extensive customer base and high quality services in industrial scale for the life science industries and academic research institutions around the world. For further information, please visit the Eurofins Genomics website.
About Eurofins – a global leader in bio-analysis
Eurofins Scientific, through its subsidiaries (hereinafter “Eurofins” or “the Group”), believes it is a 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 clinical diagnostic testing. With over 47,000 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 biological substances and products, as well as providing innovative clinical diagnostic testing services. The Group’s objective is to provide 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 companies 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).
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.
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.
Eurofins Central Laboratory and Eurofins Bioanalytical Services are member of Eurofins BioPharma Services, Laboratory Testing.
Eurofins BioPharma Services, Laboratory Testing is a full service global organization with dedicated testing facilities for Early Clinical Development, Central Laboratory Services, Bioanalytical Services, Virology and Immunology Testing Services, Anatomic Pathology and Genomics Services. As a division of the Eurofins Scientific Group, our sole and only focus is clinical laboratory analysis.