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

By Agendia B.v., PRNE
Tuesday, March 16, 2010

12 Cancer Drugs Tested, 20 Leading U.S. Cancer Centers Involved

HUNTINGTON BEACH, California and AMSTERDAM, March 17, 2010 - 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

For the official announcement of the launch of I-SPY 2 and more
information on The Biomarker Consortium, please go to:

For background information on the I-SPY 2 trial, please go to

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.

MEDIA CONTACTS: Hans Herklots, Head of Corporate Communications, Agendia, +31-20-462-1557 Office, +31-620-083-509 Mobile, hans.herklots at; Valerie Delva,
Account Executive, Ricochet Public Relations, +1-212-679-3300 x131 Office, vdelva at

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