KRAS Diagnostic Test That Assists With Personalized Treatment of Colorectal Cancer Receives CE Mark

PLEASANTON, California, July 22, 2011 -

- cobas KRAS
Mutation Test identifies colorectal cancer patients not likely to
respond to anti-EGFR antibody therapies.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the
cobas KRAS Mutation Test is now commercially available in Europe
for use in colorectal cancer.

The cobas KRAS Mutation Test identifies mutations in the KRAS
gene of colorectal cancer tissue that are predictive of individual
response to therapy with anti-epidermal growth factor receptor
(EGFR) antibody therapies.

“By quickly and reliably detecting KRAS mutations, the cobas
KRAS Mutation Test provides oncology professionals with a new,
validated tool to help guide and personalize treatment of
colorectal cancer,” said Paul Brown, head of Roche Molecular
Systems (RMS), the business area of Roche that developed the
test.

KRAS mutations occur in 35 to 45 percent of colorectal cancers.
The remaining tumors (approximately 60 percent) have no KRAS
mutations, and are referred to as KRAS wild type. The cobas KRAS
Mutation Test was designed to detect KRAS mutations with high
sensitivity, which is important because of the safety issues of
treating mutation positive patients with anti-EGFR monoclonal
antibody therapies. The test detects mutations in codons 12, 13 and
61 of the KRAS gene.

There is strong evidence that tumor KRAS status is a predictive
biomarker of efficacy for EGFR-targeted monoclonal antibodies.
Treatment with EGFR-targeted monoclonal antibodies is beneficial in
patients with KRAS wild-type colorectal cancer, whereas it is not
effective, or may even be detrimental, in patients with KRAS
mutations.

International oncology organizations such as the American
Society of Clinical Oncology (ASCO),(1) the National Comprehensive
Cancer Network (NCCN)(2) and the European Society for Medical
Oncology (ESMO) recommend KRAS mutation testing for the selection
of patients to receive anti-EGFR antibody therapy.(3) United States
and European regulatory authorities have restricted the use of
these agents to patients with KRAS wild-type tumors.

About the cobas KRAS Mutation Test and
the cobas 4800 System, v2.0

The cobas KRAS Mutation Test is a TaqMelt™, polymerase chain
reaction-based diagnostic test intended for the detection of
mutations in codons 12, 13 and 61 of the KRAS gene. The cobas KRAS
Mutation Test is now commercially available in countries that
recognize the CE mark.

The cobas 4800 System v2.0 offers high-performance amplification
and detection coupled with software that automates thermal cycling
conditions, results interpretation, analysis and reporting. The
cobas 4800 System v1.1 was recently approved in the US and all
countries accepting a CE mark.

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 2009, Roche had over 80,000 employees
worldwide and invested almost 10 billion Swiss francs in R&D.
The Group posted sales of 49.1 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: href="www.roche.com/">www.roche.com.

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

(1) Allegra CJ, Jessup JM, Somerfield MR, et al. American
Society of Clinical Oncology provisional clinical opinion: testing
for KRAS gene mutations in patients with metastatic colorectal
carcinoma to predict response to anti-epidermal growth factor
receptor monoclonal antibody therapy. J Clin Oncol 2009 Apr
20;27(12):2091-6.

(2) National Comprehensive Cancer Network. NCCN Clinical
Practice Guidelines in Oncology. Colon cancer, 2010, v.2.

(3) Van Cutsem E, Oliveira J; ESMO Guidelines Working Group.
Advanced colorectal cancer: ESMO clinical recommendations for
diagnosis, treatment and follow-up. Ann Oncol 2009 May;20 Suppl
4:61-3.

For more information please contact:
Roche Molecular Systems, Inc.
+1-888-545-2443

.