Agendia to Play Pivotal Role in ISPY-2 Trial for Breast Cancer

HUNTINGTON BEACH, California and AMSTERDAM, March 17, 2010
(ots/PRNewswire) -- Agendia, a world leader in molecular cancer
diagnostics, announced today it will participate in the highly
anticipated I-SPY 2 TRIAL for breast cancer, set to launch at the
first of nearly twenty research sites. I-SPY 2 is an exciting and
groundbreaking new clinical trial model that will help scientists
quickly and efficiently test the most promising drugs in development
for women with higher risk, rapidly growing breast cancers-women for
whom an improvement over standard treatment could dramatically change
the odds of survival. I-SPY is an initiative of the Biomarkers
Consortium, a unique public-private partnership that includes the
Food and Drug Administration (FDA), the National Institutes of Health
(NIH), and major pharmaceutical companies, led by the Foundation for
the National Institutes of Health (FNIH).

"Cancer tumor profiling in the neoadjuvant setting is critical to
the success of the I-SPY 2 trial. Agendia is uniquely positioned to
be a part of the Biomarker Consortium in this landmark study, and
proud to be working side by side with a large number of visionary
therapeutic companies and research centers," said Bernhard Sixt,
Chief Executive Officer of Agendia. "Agendia's MammaPrint test has
proven value for breast cancer recurrence in the neoadjuvant and
adjuvant settings, Agendia's TargetPrint provides objective,
quantitative information about the expression of ER, PR and Her-2neu,
while our DiscoverPrint measures the expression of the whole genome.
In concert they will form an integral part of the clinically
relevant discoveries the Consortium aims to make."

Scientists from the National Cancer Institute (NCI), FDA, and
nearly 20 major cancer research centers across the United States have
united to develop and conduct this unprecedented large-scale
scientific collaboration to test novel breast cancer drugs in the
neoadjuvant clinical trial setting. Results will be made broadly
available to the cancer research and development community in order
to foster this integrated approach to improve clinical trial success
and the efficacy of cancer therapeutics.

The adaptive design of the I-SPY 2 trial promises to integrate
and advance multiple biomarker types into a new generation of
predictive signatures. This approach has the potential to both
streamline Phase III trial designs and yield a new generation of
personalized diagnostic tools with regulatory acceptance and
approval. Information from Agendia's whole genome expression
profiling, essentially "snapshots" of tumor biopsies before and after
administration of the neoadjuvant therapies under investigation,
combined with data from the other trial participants, promises to
accelerate trials, reduce patient enrollment numbers, and generate
huge savings for commercial, research and governmental institutions.

I-SPY 2 has been officially launched at a press conference
earlier today at the National Press Club in Washington, DC. The
archived webcast of the event, including both general and scientific
Q&A sessions following the speakers' remarks, can be accessed at

http://www.visualwebcaster.com/I-SPY2-Launch

For the official announcement of the launch of I-SPY 2 and more
information on The Biomarker Consortium, please go to:
http://www.biomarkerconsortium.org

For background information on the I-SPY 2 trial, please go to
http://ispy2.org

About MammaPrint(R)

MammaPrint is the first and only breast cancer recurrence test
cleared by the U.S. Food and Drug Administration (FDA). FDA
clearance under the in vitro diagnostic multivariate index assay
(IVDMIA) guidelines requires clinical and analytical validation and
reporting systems to ensure patient safety issues are addressed.
Highly accurate, MammaPrint identifies patients with early metastasis
risk - patients who are likely to develop metastases within five
years following surgery. Several authoritative studies have shown
that chemotherapy particularly reduces early metastasis risk. In
planning treatment, the MammaPrint test results provide doctors with
a clear rationale to assess the benefit of chemotherapy in addition
to other clinical information and pathology tests.

All MammaPrint tests are conducted in Agendia's CAP-accredited
and CLIA compliant service laboratories. Breast cancer recurrence
assays currently marketed by other manufacturers have not been
subject to the rigorous FDA clearance process.

About Agendia

Agendia is at the forefront of the personalized medicine
revolution, striving to bring more effective, individualized
treatments within reach of patients. Building on a cutting-edge
genomics platform for tumor gene expression profiling, the company's
tests help physicians more accurately tailor cancer treatments.
Agendia markets four products, with several new genomic tests under
development. In addition, Agendia collaborates with pharmaceutical
companies to develop highly effective personalized drugs in the area
of oncology. Agendia is based in Huntington Beach, California, and
in Amsterdam, The Netherlands.

Rückfragehinweis:
CONTACT: MEDIA CONTACTS: Hans Herklots, Head of Corporate
Communications,Agendia, +31-20-462-1557 Office, +31-620-083-509
Mobile,[email protected]; Valerie Delva, Account Executive,
Ricochet Public Relations, +1-212-679-3300 x131
Office,[email protected]

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