Agendia to Provide Testimony at Public Meeting on FDA Oversight of Laboratory-Developed Tests

Irvine, California, and Amsterdam, July 15, 2010 (ots/PRNewswire) -
Agendia, a world leader in molecular cancer diagnostics, announced
today that company CEO Dr. Bernhard Sixt will provide testimony at a
public meeting on July 20 in Washington D.C. on the federal
regulation of laboratory developed tests (LDTs). Jointly organized by
the Food and Drug Administration (FDA) and Center for Devices and
Radiological Health (CDRH), the Public Meeting on Oversight of
Laboratory Developed Tests will be a forum for key stakeholders,
including laboratory professionals, clinicians, patients and industry
leaders, to discuss and define the issues surrounding LDT regulation
which pose the greatest risk to the public health. Dr. Sixt will
present in Session II, "Oversight of LDTs: Clinical Laboratory
Challenges."

Since the implementation of the 1976 Medical Device Amendments,
the FDA has exercised enforcement discretion over LDTs, but has not
pursued active regulation of the category. However, in recent years
these tests have become increasingly complex and high risk in nature,
and are playing an important role in clinical decision-making. As a
result, the FDA has decided that LDTs which have not been properly
validated put patients at risk, and that a risk-based application of
oversight for the category is appropriate.

Agendia joins the FDA among other leading organizations,
including Genentech, the College of American Pathologists, and the
Genetics & Public Policy Center at Johns Hopkins University, in
calling for a tiered risk-based approach to the regulation of LDTs.
As the nation's leading authority for patient safety, Agendia
believes that only the FDA can regulate the LDT category in a uniform
and unbiased manner to ensure that all claims are validated, data is
accurate and post-market surveillance is in place. Moreover, Agendia
believes that holding the LDT category to the rigors of FDA scrutiny
will inspire greater confidence among investors to enter this
emerging market, foster a level playing field among molecular
diagnostics companies and encourage the best technology to come to
the fore in personalized medicine.

As the developer of the first and only FDA-cleared breast cancer
recurrence test, MammaPrint, Agendia has led by example in the
molecular diagnostics industry by embarking on a path of regulatory
compliance. Agendia believes that patients and physicians deserve to
be fully informed about the benefits and risks of medical
diagnostics, and that all companies developing these devices should
be held accountable for the claims and safety of their tests.

The FDA will collect and review all comments and information
presented at this public meeting towards the development of a draft
oversight framework for public comment. The meeting will be held on
July 19 (8:00 a.m. to 5:00 p.m.) and July 20 (8:00 a.m. to 5:30 p.m.)
at The Marriott Inn and Conference Center, University of Maryland
University College.

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

Contact:
CONTACT: MEDIA CONTACTS: Hans Herklots, Agendia Ricochet,
+31-20-462-1557Office, +31-620-083-509 Mobile,
hans.herklots@agendia.com; Todd Aydelotte,Public Relations,
+1-212-679-3300 x123 Office, todd@ricochetpr.com