Roche Receives FDA Approval for Acute Hepatitis B Test

INDIANAPOLIS, Oct. 31, 2011 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the U.S. Food and Drug Administration (FDA) granted
Premarket Approval (PMA) for its IgM antibody to hepatitis B core antigen
(Anti-HBc IgM) assay for use on the cobas e 601 analyzer, the immunoassay module
of the cobas® 6000 analyzer series for mid-volume laboratories. The test
represents the final component of the acute panel within the hepatitis test menu
for the cobas 6000 series.

The Anti-HBc IgM assay is used for the in-vitro qualitative determination of IgM
antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma.
The presence of anti-HBc IgM, in conjunction with other laboratory results and
clinical information, is indicative of an acute or recent hepatitis B virus
(HBV) infection.* The assay is intended for use with Roche’s
electrochemiluminescence (ECL) technology, a highly sensitive light detection
system that provides excellent low-end sensitivity and broad dynamic measuring
ranges.

With this approval, Roche now offers a full selection of hepatitis tests in its
immunoassay portfolio: HBsAg, HBsAg Confirmatory, Anti-HBs, Anti-HCV, Anti-HAV,
Anti-HAV IgM, Anti-HBc IgM (approved for cobas e 601 analyzer) and Anti-HBc
(approved for MODULAR ANALYTICS E170 analyzer). The combination of full
hepatitis menu with the lowest assay duration on the market, the broadest
integrated menu and ECL technology allows the Roche total solution to inspire
confidence in the laboratory environment. The Anti-HBc IgM assay is also pending
FDA approval for use on Roche’s cobas e 411 and MODULAR ANALYTICS E170
analyzers. Roche’s current analyzer portfolio offers labs short assay duration
(9 to 27 minutes) and the broadest test menu available on an integrated
platform.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is
the world’s largest biotech company with truly differentiated medicines in
oncology, virology, inflammation, metabolism and CNS. Roche is also the world
leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in
diabetes management. Roche’s personalized healthcare strategy aims at providing
medicines and diagnostic tools that enable tangible improvements in the health,
quality of life and survival of patients. In 2010, Roche had over 80,000
employees worldwide and invested over 9 billion Swiss francs in R&D. The Group
posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly
owned member of the Roche Group. Roche has a majority stake in Chugai
Pharmaceutical, Japan. For more information: www.roche.com or
www.roche-diagnostics.us.

*The Elecsys Anti-HBc Igm immunoassay’s performance has not been established for
the monitoring of HBV disease or therapy.

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

For further information, please contact:

Betsy Cox
Director, Corporate Communications
Roche Diagnostics Corporation
Indianapolis, IN
(317) 521-3911
betsy.cox@roche.com

SOURCE Roche Diagnostics