Roche Submits Total Vitamin D Assay to FDA for Clearance on Cobas Immunoassay and Elecsys Analyzers

INDIANAPOLIS, Dec. 5, 2011 /PRNewswire/ –
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has filed a 510(k)
submission to the U.S. Food and Drug Administration (FDA) for a fully automated,
total vitamin D assay (25-hydroxyvitamin D) for use on Roche’s full portfolio of
laboratory analyzers.* The Elecsys® vitamin D test can be combined with routine
testing on existing Roche immunoassay analyzers and integrated
chemistry/immunoassay systems, enabling labs to address the growing demand for
vitamin D testing while maximizing their productivity.

“The demand for vitamin D testing is increasing rapidly as global deficiency
rates rise and studies show a link between insufficiency and disease states,”
said Randy Pritchard, vice president of marketing at Roche Diagnostics
Corporation. “This new test will give healthcare providers confidence in their
patient results and, at the same time, enable labs to integrate vitamin D
testing into their existing workflow, to save time and maintain ‘lean’
operations. Roche currently offers the largest menu available on integrated
systems, and the submission of the Vitamin D assay demonstrates our continued
commitment to the development of assays that can help improve patient care.”

According to the National Institutes of Health Office of Dietary Supplements,
the serum concentration of 25(OH)D is the best indicator of vitamin D status. It
reflects vitamin D produced cutaneously(D3) and obtained from food and
supplements (D2 and D3). The ability of an assay to detect both D2 and D3 forms
(total vitamin D) is important for physicians who have patients taking vitamin
supplements.

The assay is designed for use on all Roche immunoassay systems for low-, mid-
and high-volume testing environments, including the Elecsys 2010, cobas e 411,
cobas e 601, cobas e 602 and MODULAR ANALYTICS E170 analyzers. The FDA has a
90-day period after the 510(k) submission 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.

* This product is not cleared or available for use in the U.S. A 510(k)
submission is pending.

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