Viracor Eurofins Receives Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SARS-CoV-2 RT-PCR laboratory-developed test (LDT)
LEE'S SUMMIT, Mo., April 8, 2020 /PRNewswire/ -- Eurofins, a global leader in testing and laboratory services, announces that Viracor Eurofins, one of the largest and most recognised infectious diseases testing laboratories in the U.S., was granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Clinical Diagnostics' molecular laboratory-developed test (LDT). The Viracor SARS-CoV-2 assay is a real-time polymerase chain reaction (RT-PCR) test intended for the qualitative detection of SARS-CoV-2 viral RNA in nasopharyngeal swab, nasal swab, nasopharyngeal wash, nasal wash, oropharyngeal swab and bronchoalveolar lavage from individuals suspected of COVID-19. The Viracor EUA is available on https://www.fda.gov/media/136740/download.
Viracor Eurofins is providing results one to two days from the specimen receipt for SARS-CoV-2 testing.
According to the FDA, the test may only be performed at Viracor Eurofins' CLIA-certified (Clinical Laboratory Improvement Amendments) laboratory.
About Viracor Eurofins
Viracor Eurofins is a leader in specialty clinical diagnostics with over 35 years and 3000 test offerings in infectious diseases, transplantation, immunology and allergy, to aid diagnosis, treatment and monitoring. Viracor Eurofins is committed to helping medical professionals, transplant teams, reference laboratories and biopharmaceutical companies get results faster, when it matters most. For more information about the company and new test, please visit: https://www.viracor-eurofins.com/test-menu/8300-Coronavirus-SARS-CoV-2-RT-PCR.
As a member of Eurofins Scientific, a global leader in laboratory services for specialty clinical diagnostics, discovery pharmacology and supporting clinical studies, Viracor serves many leading biopharmaceutical companies and a wide range of clinical and academic customers in the U.S.
Viracor is a 100 percent subsidiary of Eurofins Scientific (EUFI.PA), the global leader in bio-analytical testing, and one of the world leaders in genomic services. For more information, please visit https://www.eurofins.com/ and https://www.viracor-eurofins.com/.
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).