Agendia Receives Fifth FDA Clearance for Industry Leading MammaPrint(R) Assay

By Agendia B.v., PRNE
Tuesday, February 22, 2011

IRVINE, California and AMSTERDAM, February 23, 2011 - Agendia, a world leader in molecular cancer diagnostics, today
announced that the company has received its fifth U.S. Food and Drug
Administration (FDA) clearance for MammaPrint(R), its widely used breast
cancer recurrence assay. The new clearance is comprised of two additional
Agilent Microarray scanners and two Agilent Bioanalyzers, expanding
laboratory capacity to handle the increasing number of MammaPrint,
TargetPrint(R) and BluePrint(R) test requests. The company said that the
presence of FDA cleared equipment in both of its locations will further
mitigate risk posed by a potential interruption to its business in the event
of an equipment breakdown at either location. MammaPrint previously received
several FDA clearances for clinical use in the U.S. and remains the first FDA
cleared IVDMIA (In Vitro Diagnostic Multivariate Index Assay) on the market
and the only FDA cleared breast cancer recurrence test

"Agendia continues to lead by example in the genomic testing
industry by ensuring that our products and equipment are in full compliance
with the most recent FDA standards, despite the fact that such oversight is
not mandatory," said Dr. Bernhard Sixt, Agendia's CEO and founder.

MammaPrint was previously defined by the FDA as a qualitative
in vitro diagnostic test service, performed only in Agendia's Irvine labs.
The latest FDA clearance defines a new "intended use" which allows for the
test to be performed in a central laboratory. This empowers Agendia to
legally perform tests for the U.S. market in both the Irvine and Amsterdam
CLIA and CAP accredited facilities, and also additional future central labs
under Agendia control.

About Agendia

Agendia (www.agendia.com/) 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.

Media Contact: Valerie Carter, Ricochet Public Relations, +1-202-316-0143 Mobile, vcarter at ricochetpr.com

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