Eurofins Technologies announces the launch of its CE-IVD marked multiplex Real-Time RT-PCR (reverse-transcriptase polymerase chain reaction) assay for the direct qualitative pathogen detection of the novel coronavirus (SARS-CoV-2). Particularly in the early phase of COVID-19 infection, the direct and precise diagnostic of the pathogen is key. PCR is the method of choice to detect acute coronavirus infections.
The development of the assay has been spearheaded by affiliate companies Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH and NovaTec Immundiagnostica GmbH. These specialized diagnostic technologies companies are well-established providers of testing solutions with a strong focus on scientific excellence in infectious diseases testing. They have been collaborating closely with Eurofins scientists around the world in the design and validation of the new product.
The GSD NovaPrime® SARS-CoV-2 (COVID-19) is a Multiplex Real-Time PCR for the direct qualitative pathogen detection of SARS-CoV-2. The assay simultaneously detects two target sequences inside the N gene. The multiplex PCR allows a streamlined workflow in one reaction and provides results in approximately two hours. An extraction/inhibition control and a positive control are included in the reagents.
The PCR assay demonstrates excellent performance with a 100% Negative and Positive Percent Agreement (NPA, PPA) for all tested samples and no cross-reactivity with other common widely spread coronaviruses. The analytic sensitivity shows a limit of detection of 3.75 copies/reaction.
The launch of the GSD NovaPrime® SARS-CoV-2 (COVID-19) Real-Time PCR follows the commercialization of CE-IVD marked serology-based antibody detection ELISA kits that were successfully launched in April 2020.
For more information on the COVID-19 solutions, please visit: www.goldstandarddiagnostics.com
For more information, please visit www.eurofins.com or contact:
Eurofins Scientific SE
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 – 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.