Roche Obtains Co-Exclusive License to Develop PCR Assays Detecting Mutations in the PI3K Oncogene

By Roche, PRNE
Monday, July 12, 2010

PLEASANTON, California, July 13, 2010 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the company has
obtained a worldwide co-exclusive license for the biomarker PI3K
(phosphoinositide 3-kinase) from QIAGEN to develop real-time and endpoint PCR
diagnostic assays. Johns Hopkins University owns the patent for the PI3K
biomarker and has previously granted an exclusive license to QIAGEN's wholly
owned subsidiary DxS, now QIAGEN Manchester. Financial details were not

The PI3K pathway is mutated in more cancer patients than any other (1),
playing a significant role in colorectal, gastric, breast and endometrial
tumors, among others. Drugs that inhibit PI3K are a significant focus of
current cancer drug development. Genentech, a member of the Roche Group, has
several molecules in early development targeting various points along this
pathway, in a variety of tumor types.

Multiple scientific papers have shown that PI3K has the potential to be a
clinically relevant biomarker for the prediction of individual response to
specific cancer therapies. "There is abundant clinical evidence that the PI3K
biomarker will play a significant role in the future of oncology treatment,"
said Paul Brown, president and CEO, Roche Molecular Diagnostics. "Diagnostic
assays that detect mutations in PI3K will be an essential component of cancer
drug development and personalized healthcare."

Roche has an ongoing program to develop a real-time PCR assay that
detects mutations in the PI3K oncogene. The assay will run on Roche's
cobas(R) 4800 System. Roche intends to make the PI3K PCR assay available to
internal and external pharmaceutical partners for use in clinical drug

The PI3K assay will complement Roche's extensive menu in development of
assays for validated biomarkers, including the B-RAF V600E mutation, found in
greater than 50 percent of melanomas.

"Given the demonstrated predictive value of these biomarkers, developing
assays that identify clinically relevant mutations is an area of high
priority for Roche," said Brown. "By applying our vast, global experience in
both cancer drug development and molecular diagnostics, we believe we can
quickly generate new assays that will provide value to both drug developers
and oncology medical professionals."

About the cobas(R) 4800 System

The cobas(R) 4800 System is designed to deliver new standards in
laboratory testing efficiency and medically relevant diagnostic information
with increased testing throughput. The system combines state-of-the-art
sample preparation with Roche's proprietary real-time PCR technology for the
amplification and detection of genetic material (deoxyribonucleic acid or
DNA). The intuitive, easy-to-use software integrates sample preparation,
amplification and detection, and results management.

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

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

1) American Association for Cancer Research.–media/stand-up-to-cancer/su2c-dream-teams/ta

    For more information please contact:

    Brien Mahoney
    Manager, Corporate Communications
    Roche Molecular Systems, Inc.
    tel +1-925-699-8512

Brien Mahoney, Manager, Corporate Communications of Roche Molecular Systems, Inc., +1-925-699-8512, brien.mahoney at

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