Viracor-IBT Laboratories Inc.’s Zika Virus RT-PCR Test Receives Emergency Use Authorization From the FDA
Wednesday, July 20, 2016
Test Provides U.S. Physicians and Patients Same Day Results and the Option to Test Urine Alongside Blood.
Viracor-IBT Laboratories Inc. (Viracor-IBT), a wholly-owned subsidiary of Eurofins Scientific (EUFI.PA), today announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Zika Virus Real-time RT-PCR assay. Viracor-IBT will perform this assay under CLIA/CAP regulations for High Complexity Clinical Laboratories. The assay has been approved by the New York State Department of Health (NYSDOH). The proprietary molecular Zika virus test is a real-time RT-PCR assay intended for the qualitative detection of RNA from Zika virus in human serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen) collected from individuals meeting Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated).
Viracor-IBT’s Zika Virus Real-time RT-PCR has excellent sensitivity and does not cross-react with other viruses in the Flaviviridae family (including dengue virus, Japanese encephalitis virus, West Nile virus and St. Louis encephalitis virus) or with other viruses known to cause similar clinical symptoms such as chikungunya virus. According to the Centers for Disease Control and Prevention (CDC), during the first week after onset of symptoms, Zika virus disease can often be diagnosed by performing real-time reverse transcription-polymerase chain reaction (RT-PCR) on serum. Additionally, urine samples collected less than 14 days after onset of symptoms are recommended for RT-PCR testing, when collected alongside a patient-matched serum or plasma specimen.
Dr. Gilles Martin, Eurofins’ CEO said, “As a leader and trusted laboratory partner specialized in and dedicated to improving patient care through innovative infectious disease testing, Viracor-IBT is thrilled to be one of the first commercial laboratories to offer the Zika RT-PCR test to hospitals and health systems, and we are pleased that the FDA recently authorized our assay. Viracor-IBT’s Zika test provides timely, accurate results and more testing options to doctors and patients.”
Zika virus is primarily spread through mosquitos and can also be spread by some forms of sexual contact. Zika virus has been linked to microcephaly in newborns and is at the forefront of concern for emerging infectious diseases. The Zika virus outbreak in South America has potential to further reach North America with the onset of the mosquito season, and Viracor-IBT will be prepared to assist patients by providing a fast turnaround time (within 8-12 hours of specimen receipt) on test results.
“Viracor-IBT has a proven history of developing and validating highly sensitive, accurate assays in response to emerging public health needs, like Zika virus. In 2009, Viracor-IBT was one of the first laboratories to market with the H1N1 Influenza A RT-PCR assay. We are committed to developing high quality infectious disease assays that help our clients help more patients,” said Steve Kleiboeker, PhD, HCLD/TS/CC (ABB), Vice President of Research and Development, Viracor-IBT.
Viracor-IBT’s PCR assay development goes above and beyond “traditional” real-time PCR and RT-PCR design in that redundancy is present in the assay to account for the full range of viral serotypes, genotypes or isolates that may be infecting patients. With this expert approach to assay design, a problematic viral genomic polymorphism on one target will not result in inaccurate quantification or false positive results. Like all other EUA authorizations, the Zika Virus Real-time RT-PCR test has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.
For more information please visit http://www.eurofins.com or contact:
Jenni Miller, Corporate Communications
Phone: +1800 305 5198
Phone: +32 2 766 1620
Notes for the editor:
Eurofins – a global leader in bio-analysis
Eurofins Scientific believes it is the world leader in food, environment and pharmaceutical products testing, as well as one of the global market leaders in agroscience, genomics, discovery pharmacology and central laboratory services. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.
With over 23,000 staff in more than 225 laboratories across 39 countries, Eurofins offers a portfolio of over 130,000 validated analytical methods for evaluating the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as for innovative clinical diagnostic. The Group provides its customers with high-quality services, accurate results on time and 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 the most comprehensive range of testing methods.
As one of the most innovative and quality oriented international players in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the expanding demands of regulatory authorities and healthcare practitioners around the world.
The shares of Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).
About Viracor-IBT Laboratories
With over 30 years of specialized expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Viracor-IBT is committed to helping medical professionals, transplant teams, reference laboratories and biopharmaceutical companies get results faster, when it matters most. Viracor-IBT is passionate about delivering value to its clients by providing timely, actionable information, never losing sight of the connection between the testing it performs and the patients it ultimately serves. Viracor-IBT 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 www.eurofins.com and www.viracoribt.com
This press release contains forward-looking statements and estimates that involve risks and uncertainties. The forward-looking statements and estimates contained herein represent the judgement of Eurofins Scientific’ 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 guarantee can be made as to their validity