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

World Leader in Cancer Diagnostics Joins Nation's Top Safety Agency in Calling for Risk-Based Oversight of Genomic Testing

IRVINE, California, and AMSTERDAM, July 15, 2010 - 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.

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