22-Jul-2016 - Viracor-IBT Laboratories

Zika virus test receives FDA emergency use authorization

Test provides 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), 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.

More about VIBT
  • News

    Eurofins acquires VIBT

    Eurofins Scientific has signed a definitive agreement to acquire ViraCor-IBT Laboratories, Inc. from majority owner Ampersand Capital and other shareholders for approximately $255m, subject to post-closing adjustments. Comment from Dr. Gilles Martin, Eurofins CEO: “This acquisition reflects ... more

More about Eurofins
  • News

    Eurofins scientific acquires two North American companies

    By acquiring EnvironeX Group Inc. in Canada and TestAmerica in the USA Eurofins expands its testing capabilities in the North American market. EnvironeX Group Inc. - bioanalytical testing in Canada Founded in 2005 by Marc Hamilton and supported by PCP since 2015, EnvironeX is a leading prov ... more

    Eurofins acquires German pharma quality service company

    Eurofins Scientific announces that it has signed an exclusive agreement to acquire PHAST Gesellschaft für Pharmazeutische Qualitätsstandards mbH (“PHAST”), one of Europe’s leading service providers in the field of pharmaceutical products quality. The transaction is expected to close in the ... more

    Eurofins expands its footprint in Asia with the acquisition of Lab Frontier in South Korea

    Eurofins Scientific (EUFI.PA) announces that it has successfully closed the transaction to acquire Lab Frontier Co., Ltd., which provides a broad suite of food, environment and cosmetics testing services in South Korea. Lab Frontier, an affiliate company of Young In Group (YIG), will furthe ... more

  • Companies

    Eurofins Genomics Germany GmbH

    FAST. We produce and analyze DNA & RNA Eurofins Genomics, a member of the Eurofins Group with facilities in Europe, USA and Asia, is an internationally leading provider of DNA sequencing services, genotyping services, DNA synthesis products and bioinformatics services for pharma, diagnosti ... more

    Eurofins Medigenomix GmbH


    Eurofins Genomics B.V.

    Eurofins Scientific is a life sciences company operating laboratories in 30 countries to provide a comprehensive range of analytical testing services drawing on the latest developments in biotechnology. The Group specialises in delivering analytical testing and advisory services to clients ... more