Agendia Successfully Completes Bi-Annual FDA Inspection
IRVINE, California and AMSTERDAM, October 3, 2011 /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.
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
SOURCE Agendia B.V.