Agendia Successfully Completes Bi-Annual FDA Inspection

Irvine, California and Amsterdam (ots/PRNewswire) -

Agendia, an innovative molecular cancer diagnostics company, today
announced that the company successfully completed a recent, routine
inspection of its Irvine, California-based laboratories by the US
Food and Drug Administration (FDA). Agendia received FDA 510(k)
clearance for its MammaPrint(R) breast cancer recurrence test in
early 2007. It remains the first and only test of its kind to receive
FDA clearance, which, in addition to validiation of the product's
safety and efficacy, periodically subjects the company's laboratories
to the scrutiny of FDA inspectors to ensure continuous compliance
with regulations.

"Agendia was founded on the principle of providing safe and
effective products to improve patients' quality of life, and we have
gone to great lengths to ensure that MammaPrint meets this high
standard," said Dr. Bernhard Sixt, CEO and co-founder of Agendia.
"Ensuring the safety of MammaPrint doesn't just stop at the approval
process. We must ensure that MammaPrint continues to comply with
regulations throughout the life of the test. This is why we sought
FDA clearance and why we believe the industry, as a whole, should be
regulated in the same manner. I am immensely proud that FDA has once
again validated Agendia's MammaPrint test and take even greater pride
to offer the only breast cancer recurrence test that has been
subjected to such painstaking FDA oversight."

FDA inspectors thoroughly examined Agendia's facilities,
evaluating the company's compliance with FDA's Good Manufacturing
Practice Regulations (GMP), which require manufacturers of drugs,
medical devices and FDA cleared laboratory tests to ensure product
safety and effectiveness. GMP regulations compel companies, such as
Agendia, to employ strong manufacturing practices that minimize or
eliminate the risk of contamination, laboratory mixups and errors.
FDA inspectors assessed Agendia's laboratory operations from top to
bottom, including recordkeeping, personnel, sanitation and
cleanliness, equipment, process validation and complaint handling.
This meticulous inspection ensures the reliability and safety of
Agendia's MammaPrint test, and protects patients.

About Agendia:

Agendia [http://www.agendia.com ] is a leading global commercial
molecular diagnostic company that develops and markets genomic-based
diagnostic products that improve the quality of life for cancer
patients and simplifies complex treatment decisions for their
physicians. Agendia's Symphony(TM) suite of breast cancer products is
based on the analysis of hundreds of genes in a patient's breast and
provides unprecedented biological insight to address complex
treatment decisions. Symphony includes MammaPrint, the first and only
FDA-cleared IVDMIA breast cancer recurrence assay, as well as
BluePrint, a molecular subtyping assay, TargetPrint(R), an ER/PR/HER2
expression assay, and TheraPrint(R), a therapy selection assay.
Together, these tests help physicians determine a patient's
individual risk for metastasis, which patients will benefit from
chemo or hormonal therapy, and which patients do not require these
treatments and can instead be treated with other less arduous and
costly methods.

In addition to the Symphony suite of tests, Agendia has a rich
pipeline of genomic products in development based on its world-class
genomic platform. The company also collaborates with pharmaceutical
companies to develop companion diagnostic tests in the area of
oncology and is a critical partner in the ISPY-2 and MINDACT trials.

Agendia was founded in 2003 as a spin-off of the Netherlands
Cancer Institute and is based in Irvine, California, United States,
and Amsterdam, the Netherlands. For more information, please visit
http://www.agendia.com.

Rückfragehinweis:
For further information, please contact: Ricochet Public
Relations, Valerie Carter, Tel: +1-202-316-0143, E-mail:
[email protected]

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