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Agendia Inaugurates New State-of-the-Art Genomics Laboratory in Irvine

Irvine, California, and Amsterdam, August 5, 2010 (ots/PRNewswire)

Agendia, a world leader in molecular cancer diagnostics, today
announced the inauguration of a new state-of-the-art clinical
genomics laboratory in Irvine, CA. Previously, Agendia's offices and
laboratory were located in Huntington Beach, CA. The new laboratory
will further increase capacity to support Agendia's strong commercial
expansion in the U.S. market, as well as the use of multiple Agendia
tests in clinical research. MammaPrint, the company's lead product
and the only FDA-cleared breast cancer recurrence test, is reimbursed
by an increasing number of payers, covering some 100 million lives
today.
(Photo: http://www.newscom.com/cgi-bin/prnh/20100805/402822-a )
(Photo: http://www.newscom.com/cgi-bin/prnh/20100805/402822-b )
In addition, MammaPrint plays a central role in the recently
initiated I-SPY 2 trial, which is a revolutionary breast cancer trial
and an initiative of the Biomarkers Consortium, a unique
public-private partnership that includes the Food and Drug
Administration, the National Institutes of Health, and major
pharmaceutical companies, led by the Foundation for the National
Institutes of Health. The I-SPY 2 trial, which will enroll patients
at 20 leading U.S. cancer research centers, will also rely on
Agendia's TargetPrint to provide objective, quantitative information
about the expression of the specific tumor-related proteins, ER, PR
and Her-2neu, while Agendia's DiscoverPrint will measure the
expression of the whole genome for all enrolled patients. These tests
allow the study researchers to more quickly identify which
investigational drugs offer the most benefit for women with certain
tumor characteristics.
The new Irvine facility consists of corporate offices and a
15,000 square foot, state-of-the-art genomics laboratory. A large
group of California politicians and other VIPs attended the
inauguration, including the Mayor of Irvine, Sukhee Kang, and
representatives of patient organizations and clinicians.
"Our new genomics lab's capacity will allow us to meet the
increasing demand for MammaPrint across the United States and give
physicians and patients optimal test result turnaround and unmatched
service and support," said Dr. Bernhard Sixt, President and Chief
Executive Officer. "This expansion places us in an excellent position
to continue making advancements in molecular cancer diagnostics and
equip oncologists with powerful tools to use in the fight against
breast cancer."
As the U.S. Food and Drug Administration prepares to regulate
Laboratory Developed Tests (LDTs) for the first time, Agendia finds
itself in an exceptionally strong position, having already secured 4
separate FDA IVDMIA clearances for MammaPrint, establishing the
company as the only developer of a breast cancer recurrence test that
is already validated by the FDA. The launch of the new Irvine
facility speaks to the company's growth and success in the US
marketplace.
Ongoing research and development commitments continue to augment
Agendia's ability to accurately predict breast cancer recurrence and
sub-typing, and help physicians tailor individual treatment plans to
their patients. Agendia's goal is to provide women with answers to
crucial treatment questions, such as how their breast cancer will
respond to targeted therapies or various chemotherapy regimens.
For more information, please visit http://www.agendia.com
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
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.
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 Irvine, California, and in
Amsterdam, The Netherlands.

Contact:

CONTACT: Media Contacts: Hans Herklots, Agendia, +31-20-462-1557
Office,+31-620-083-509 Mobile, hans.herklots@agendia.com; Todd
Aydelotte, RicochetPublic Relations, +1-212-679-3300 x111 Office,
todd@ricochetpr.com

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