Roche launches cobas Zika blood screening test to markets accepting the CE mark

• Zika virus infection is linked to brain defects in fetuses and newborn infants as well as neurological complications in children and adults
• Asymptomatic Zika virus infection in blood donors can pose a risk to the blood supply
• cobas® Zika expands Roche’s industry-leading donor screening portfolio for blood-borne diseases in the CE market

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the CE-IVD launch of the cobas® Zika test for use on the cobas® 6800/8800 Systems. The cobas® Zika test detects Zika virus RNA in samples of human plasma and is intended for use in screening blood donations. Building onto Roche’s comprehensive menu of donor screening assays, this launch represents an important milestone in the effort to protect the blood supply from Zika virus globally. Recent news from French authorities reporting three cases of Zika infection apparently acquired locally¹ highlights ongoing Zika activity and the need for blood bank preparedness solutions for tropical diseases.

The Zika virus is mainly spread through the bite of infected mosquitoes. However, it is suspected that infected donor blood used for transfusions could serve as an additional transmission route for the Zika virus.

Together with cobas® CHIKV/DENV to screen for chikungunya and dengue viruses, the cobas® Zika test provides a solution for preserving blood safety in regions with local outbreaks of these tropical diseases or from donors who may have been exposed while traveling to outbreak areas,

 said Mario Torres, Head of Roche Molecular Diagnostics.

Launching the cobas® Zika test in markets accepting the CE mark expands the emergency preparedness solution for our customers and helps minimize the risk of transmission through infected blood and plasma donations.

Roche worked closely with the U.S. Food and Drug Administration to develop and launch the cobas® Zika test in response to a public health crisis and ensure the safety of blood in the U.S. and its territories in 2017. Since then, the cobas® Zika test has been used to screen millions of blood donations from the U.S. and Puerto Rico, helping to identify and remove more than 350 potentially infectious donations from the blood supply. Every year, there are more than 117 million blood donations worldwide.² One blood donation has the potential to save as many as three lives, making a safe supply of blood and blood products extremely important for any patient that needs a transfusion.

Manufactured by Roche, the cobas® Zika test for use on the cobas® 6800/8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from donors of whole blood and blood components, and other living donors. Together with the cobas® 6800/8800 Systems, the cobas® Zika test provides solutions for blood services to detect the Zika virus and ensure that potentially infected blood units are not made available for transfusion. The fully automated cobas® 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms, providing donor screening laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands. The cobas® Zika CE-IVD test is the latest addition to Roche’s assay menu for donor screening laboratories — which includes cobas® MPX, cobas® DPX, cobas® HEV, cobas® WNV, cobas® CHIKV/DENV and cobas® Babesia (FDA approved, not commercially available) — all of which run on the cobas® 6800/8800 Systems. Not all assays are available in all markets.

Since 2014, the cobas® 6800/8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of donor screening, infectious disease, sexual health, transplant, respiratory and antimicrobial stewardship.

The Zika virus belongs to the Flaviviridae family of viruses, which includes dengue, yellow fever, Japanese encephalitis and West Nile viruses. Zika is mainly spread by the bite of infected mosquitoes; however, transmission through sexual intercourse and from pregnant mothers to fetuses has also been documented.³ A growing body of evidence confirms the links between Zika virus infection and defects in fetuses and newborns, as well as neurological complications in children and adults.⁴ Similar to other viruses in the Flaviviridae family, such as West Nile virus, it is suspected that infected donor blood used for transfusions could serve as an additional transmission route for Zika virus.⁵

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.