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

Irvine, California and Amsterdam (ots/PRNewswire) -
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 (http://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.

ots Originaltext: Agendia B.V.
Im Internet recherchierbar: http://www.presseportal.de

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