Roche receives FDA approval for fully automated blood screening assay on the cobas® 6800/8800 Systems

Next generation cobas® MPX assay now approved for donor screening applications in the United States

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Oct 21, 2016, 03:04 ET

PLEASANTON, Calif., Oct. 21, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas® MPX test for use on the cobas® 6800 and 8800 Systems. The cobas® MPX test enables donor screening laboratories to apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the spread of Human Immunodeficiency Virus Groups 1 and 2 (HIV-1 and HIV-2), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through transfused blood products.

"This approval reinforces our strong presence in donor screening, and underscores our ability to provide proven, robust technology for the testing of donated blood and blood products," said Uwe Oberlaender, Head of Roche Molecular Diagnostics. "We will continue to partner with donor screening laboratories worldwide demonstrating our joint commitment to patient safety."

The fully automated cobas® 6800/8800 Systems offer the fastest time to results, the highest throughput and the longest walk-away time available among automated molecular platforms, providing blood and plasma screening laboratories with improved operating efficiency and flexibility to adapt to changing testing demands. Earlier this year, Roche initiated testing for Zika virus at U.S. blood centers under FDA Investigational New Drug Application protocol with the cobas® Zika test for use with the cobas® 6800/8800 Systems.

About the cobas® MPX assay
cobas® MPX is a nucleic acid test for the detection of HIV, HBV and HCV in human blood plasma and serum. cobas® MPX is a real-time PCR multiplex test detecting five critical viral targets: HIV-1 Group M, HIV-1 Group O, HIV-2, HBV and HCV, from a single sample. The cobas® MPX assay features a dual-target approach with amplification of separate regions of HIV-1, and dual probes for HCV. It eliminates both the need for discriminatory testing between HIV, HBV, and HCV and the potential for discrepant results.

About the cobas® 6800/8800 Systems
The cobas® 6800 and cobas® 8800 Systems are fully integrated, automated solutions that introduce a new standard for routine molecular testing in the areas of donor screening, viral load monitoring, women's health and microbiology. Based on Nobel-prize winning PCR technology, the systems are designed to deliver full automation, increased throughput and faster turnaround time, providing users with greater flexibility to increase overall workflow efficiencies.

The systems provide up to 96 results in less than 3.5 hours, and a total of 384 results for the cobas® 6800 System and 960 results for the cobas® 8800 System in an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas® 6800) and four hours (cobas® 8800) of walk-away time with minimal user interaction.

For more information about the systems, please visit www.cobas68008800.com or http://molecular.roche.com.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives.

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. 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.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine 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. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 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.

All trademarks used or mentioned in this release are protected by law.

For media inquiries, please contact:
Brien Mahoney, Roche Molecular Diagnostics
888-545-2443

SOURCE Roche