Roche announces launch of the Elecsys® Zika IgG assay heralding a significant advance in its commitment to developing diagnostic solutions for Zika virus infection
Rotkreuz, 21 March 2018
- An infection with Zika virus can cause impaired neurological development in babies, such as microcephaly1
- Diagnostic testing helps healthcare professionals to assess the immune status of patients
- The launch of Elecsys® Zika IgG assay complements recent advancements Roche has made as part of its ongoing commitment to the Zika global public health challenge
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has launched the first fully automated Zika IgG immunoassay, the Elecsys® Zika IgG immunoassay for CE Mark countries, to help detect Zika virus infection. Accurate diagnosis of an infection with Zika virus is an urgent medical need, particularly for pregnant women, as an infection with Zika virus can cause impaired neurological development in babies whose mothers were infected during pregnancy.1
Diagnostic testing enables healthcare professionals to assess the immune status of patients, which can be of particular importance to expectant mothers, their partners and travellers, and detect evidence of a recent Zika virus infection. In launching a serological assay, Roche solidifies their commitment to provide a complete diagnostic solution for countries at a high risk of infection with Zika virus.
This new serological assay complements a significant advancement from Roche for Zika virus screening. On 5 October 2017, the U.S. Food and Drug Administration (FDA) granted IVD status to the cobas® Zika test, for use with the cobas 6800/8800 systems, for the screening of blood and plasma donations in the United States.
The rapid development of both PCR and serological Zika virus assays, including cobas Zika NAT and Zika IgG antibodies, was part of the company-wide response to the World Health Organization’s declaration of a public health emergency on the rising Zika epidemic in 2016.2
“Our investment and commitment to emerging infectious diseases has allowed us to fast track the development of this new serological assay,” said Thomas Schinecker, Head of Centralised and Point of Care Solutions. “Helping healthcare professionals to assess the infection status, even when ribonucleic acid (RNA) is no longer detectable is an important step in infection control.”
Zika virus serological testing could be used for accurate diagnosis of Zika virus infection when the virus’ RNA is no longer detectable in patient’s blood sample.3 Due to the similarity of Zika virus to other viruses, such as Dengue virus, the Elecsys® Zika IgG assay was developed as a highly specific assay to limit cross-reaction and reduce the occurrence of false positive results. This assay can also be used to later determine the seroprevalence of Zika virus in different populations and countries at risk to assess the level of immune status in a country.4
“All estimates of Zika virus infection incidence in dengue endemic areas are hampered by the cross-reactivity observed in virtually all immunoassays available so far,” said Dr. José Eduardo Levi, Tropical Medicine Institute, University of São Paulo. “Moreover, accurate diagnosis, especially for pregnant women is an urgent unmet need.”
About Zika Virus
Zika virus belongs to the Flaviviridae family of viruses, including Dengue, Yellow Fever, Japanese encephalitis and West Nile viruses.5 Zika virus is mainly spread by infected mosquitoes, though transmission may also occur through mother-to-child, sexual intercourse and infected donor blood used for transfusions.6 There is now evidence that Zika virus is linked to birth defects in fetuses and newborns, and neurological complications in adults.7,8 Based on a systematic review of the scientific literature, in 2016 the World Health Organization (WHO) concluded that Zika virus infection during pregnancy may cause congenital brain abnormalities, including microcephaly; and that the virus is a trigger of Guillain-Barré syndrome and subsequently declared Zika virus as a public health emergency.9 Today, Zika virus infection remains a significant enduring public health challenge, requiring intense action, but is no longer classified as a public health emergency.10
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1. Centers for Disease Control and Prevention. Zika Virus: Microcephaly & Other Birth Defects. Available at: https://www.cdc.gov/zika/healtheffects/birth_defects.html. Last accessed: February 2018
2. World Health Organization. WHO statement on the first meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations. Available at: http://www.who.int/mediacentre/news/statements/2016/1st-emergency-committee-zika/en/. Last accessed: February 2018.
3. Centers for Disease Control and Prevention. Zika Virus: Diagnostic Tests for Zika Virus. Available at: https://www.cdc.gov/zika/hc-providers/types-of-tests.html. Last accessed: February 2018.
4. Maite Aubry, Jérôme Finke, Anita Teissier, Claudine Roche, Julien Broult, Sylvie Paulous, Philippe Desprès, Van-Mai Cao-Lormeau, Didier Musso. Seroprevalence of arboviruses among blood donors in French Polynesia. International Journal of Infectious Diseases. 2011–2013
5. Soriano-Arandes A., Rivero-Calle I., Nastouli E., Espiau M., Frick M.A., Alarcon A., Martinón-Torres F. What we know and what we don't know about perinatal Zika virus infection: a systematic review. Expert Rev Anti Infect Ther. 2018; 15: 1-12.
6. Holtzman M, Golden W.C., Sheffield J.S. Zika Virus Infection in the Pregnant Woman. Clin Obstet Gynecol. 2018; 61(1): 177-185.
7. Rasmussen, S.A, Jamieson, D.J., Honein, M.A., et al. (2016). Zika virus and birth defects: Reviewing the evidence for causality. New England Journal of Medicine. 374(20): 1981-1987.
8. World health Organization, Pan American Health Organization, Epidemiological Update: neurological syndrome, congenital anomalies, and Zika virus infection. 17 January 2016. Available at: http://www.paho.org/hq/index.php?option=com_docman&task=doc_view&Itemid=270&gid=32879&lang=en. Last accessed Feb 2018.
9. World Health Organization. . Epidemiological alert – Zika virus infection 7 May 2015. Available at: http://www.paho.org/hq/index.php?option=com_docman&task=doc_view&Itemid=270&gid=30075=en%20%28accessed%2002%20feb%202016%29 [Last accessed July 2017].
10. World Health Organization. . Fifth Meeting of the emergency committee under the International Health Regulations (2005) regarding microcephaly, other neurological disorders and Zika virus. Available at: http://www.who.int/mediacentre/news/statements/2016/zika-fifth-ec/en/ [Last accessed July 2017].