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.
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.
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SOURCE Viracor-IBT Laboratories, Inc.