Viracor Eurofins received FDA EUA for its RT-PCR SARS-CoV-2 Virus LDT.
Eurofins Genomics expands capacity for probes and primers production for RT-PCR SARS-CoV-2 test kits
Eurofins Technologies, a fast growing provider of diagnostic technologies in the field of immunoassays and molecular detection methods, announces the launch of a 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. The first ELISA assays are expected to receive CE-IVD mark by 16 April 2020 and will also be submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA).
Viracor Eurofins received FDA EUA for its RT-PCR Laboratory-Developed Test (LDT) for SARS-CoV-2 on 06 April 2020. More information can be found on Viracor Eurofins.
Due to the increasing global demand and worsening supply chain issues, Eurofins Genomics’ six oligonucleotides production sites in the U.S., Europe, India and Japan are increasing their capacity to produce probes, primers and positive controls, which are key components for RT-PCR testing of SARS-CoV-2.
Multiple solutions to support health authorities in their fight against COVID-19
A comprehensive product portfolio is essential to support the tremendous efforts of health authorities working on SARS-CoV-2 detection and COVID-19 control all over the world. Over the last six weeks, in close collaboration with leading research hospitals and many of Eurofins human clinical testing laboratories around the world, Eurofins Technologies teams have worked diligently to develop a broad range of testing methods to support healthcare providers around the world.
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 following products will be released shortly to leading reference centers and hospitals around the world:
Serology – Antibody tests for IgG, IgM, and IgA with very good specificity and sensitivity will be released for use on any open ELISA platform.
Lateral Flow – As an additional option with fast turnaround time, an easy-to-use rapid lateral flow antibodies test is under final development and validation.
Automation – Gold Standard Diagnostics offers a suite of instruments for the seamless automation of ELISA assay testing in any laboratory.
Molecular Diagnostics – A range of RT-PCR tests for the qualitative detection of SARS-CoV-2 have been developed by Eurofins laboratories around the world. These tests are designed to meet the region-specific requirements for COVID-19 targets. Viracor Eurofins received FDA Emergency Use Authorization (EUA) for its SARS-CoV-2 Laboratory Developed Test (LDT) on 06 April 2020. Other Eurofins laboratories around the world have developed alternative RT-PCR options to meet local regulatory obligations and mitigate reagent supply chain issues so Eurofins can continue to significantly increase the testing capacity it offers to health authorities fighting the disease.
Probes and Primers for RT-PCR – Eurofins Genomics is also supplying primers and probes to a large number of laboratories and clinical diagnostic developers around the world to form an essential part of their RT-PCR testing solutions. Eurofins Genomics’ six Oligonucleotides production sites around the world are increasing capacity significantly to meet the growing demand and help clinical diagnostic manufacturers and laboratories mitigate supply chain issues.
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 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.