Siemens Healthcare Diagnostics Inc. Receives Emergency Use Authorization from FDA for its VERSANT® Zika RNA 1.0 Assay (kPCR) Kit
The U.S. FDA has granted Siemens Healthcare Diagnostics Inc. (Siemens) an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT® Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika in vitro diagnostic tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical products when, among other circumstances, there are no adequate, approved, and available alternatives and certain additional criteria are met.
“The FDA’s emergency use authorization of the VERSANT® Zika RNA 1.0 Assay (kPCR) Kit from Siemens can lead us one step closer to stopping the spread of the Zika virus,” says Fernando Beils, Vice President, Head of Molecular Diagnostics, Siemens . “Being able to quickly diagnose patients will help physicians to more efficiently manage those affected.”
The VERSANT® Zika RNA 1.0 Assay (kPCR) Kit is capable of detecting the presence of Zika virus, which can be an earlier indicator of Zika virus infection than anti-Zika antibodies. The molecular test is validated for plasma, serum, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, and is designed to run on the Siemens VERSANT® kPCR Sample Prep automated platform, along with several commercially available thermal cyclers. The assay must be run by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. The VERSANT® Zika RNA 1.0 Assay (kPCR) Kit 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.
Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world’s largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of gas and steam turbines for power generation, a major provider of power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2015, which ended on September 30, 2015, Siemens generated revenue of €75.6 billion and net income of €7.4 billion. At the end of September 2015, the company had around 348,000 employees worldwide. Further information is available on the Internet at www.siemens.com .