EUROIMMUN announces option agreement on Zika virus serology

EUROIMMUN and Roche announced early April 2017 that they have entered into an option agreement under which Roche gains access to intellectual property in the field of Zika virus immunodiagnostics assigned to EUROIMMUN. In January 2016, EUROIMMUN became the first company in the world to launch antibody tests that are capable of indicating both an acute Zika virus infection (usually from the fifth day after the onset of symptoms) and previous episodes of the illness. The EUROIMMUN Anti-Zika Virus ELISA is also the first commercial serological Zika test to receive CE (Europe) and ANVISA (Brazil) Mark registrations. Infectious diseases represent a major cause of death worldwide. Every year, 1.45 million people die of viral hepatitis  and in 2014, 1.2 million died of AIDS-related causes.  After the 2014 Ebola outbreak, Zika is the latest virus to create significant public health concern. There is a growing body of evidence that links the Zika virus to birth defects in fetuses and newborns, and neurological complications in adults. Public health officials and experts in the field consider these associations valid based on a number of epidemiological studies, modelling, and use of predefined criteria. Concern among public health bodies is high since there are currently no effective interventions to control vector mosquitoes. In order to prepare for the growing health emergency, EUROIMMUN launched the Anti-Zika Virus ELISA (IgM or IgG), a fully automated, highly specific test with reduced cross-reactivity to other flaviviruses. The Anti-Zika Virus ELISA (IgM or IgG) is based on a highly specific, recombinant non-structural viral protein (NS1), which avoids the cross-reactivity typically associated with serological tests based on whole virus antigens. Data from panels of well-characterized sera have confirmed that there is no cross-reactivity with flaviviruses including dengue, West Nile, yellow fever, tick-borne encephalitis and Japanese encephalitis viruses. In studies on clinically and serologically characterized samples the IgM and IgG ELISAs showed nearly 100% specificity. Furthermore, the combination of IgM and IgG ELISAs provides highest sensitivity of 97%. Serological testing provides a much longer window for diagnosis compared to direct detection methods. This type of testing helps assess a recent infection even when ribonucleic acid (RNA) is no longer detectable – if, for example, the infection is resolved or has moved into the chronic phase. It is therefore critical that any serology assay be extremely specific to Zika to reduce cross-reaction with these other viruses, thus avoiding a potential false positive that could lead to erroneous interpretation of a patient’s immune status. “Until now it has been virtually impossible to distinguish a Zika virus infection by antibody testing from infections with other flaviviruses like dengue or West Nile virus,” said Dr. Wolfgang Schlumberger, Vice Chairman of the EUROIMMUN’s Board. “Our test may be used by travellers to areas with Zika virus outbreaks to assess any health risks and to take appropriate precautions upon return, and cooperating with Roche will help us make it available to the broadest possible spectrum of patients.”