Roche Submits Acute Hepatitis B Test to FDA for Premarket Approval

INDIANAPOLIS, July 26, 2011 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that it has submitted a Premarket Approval Application (PMA) to
the U.S. Food and Drug Administration (FDA) for the Elecsys Anti-HBc IgM assay
for use on the cobas e 411, cobas e 601 and MODULAR ANALYTICS E170 analyzers.
The hepatitis B test represents the final component of the acute panel within
the hepatitis menu on Roche’s family of immunoassay analyzers.

The PMA submission is for use of the assay in 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 acute or recent
hepatitis B virus (HBV) infection.* The assay is intended to be used with
Roche’s electrochemiluminescence (ECL) immunoassay technology.

Roche currently has seven other immunoassay tests available on its hepatitis
menu: HBsAg, HBsAg Confirmatory, Anti-HBs, Anti-HCV, Anti-HAV, Anti-HAV IgM and
Anti-HBc.

The FDA has 45 days after the PMA is received to notify Roche whether the
application has been filed. If the PMA is accepted for filing, the FDA has a
180-day period for substantive review of the application.

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