Agendia's Breast Cancer Test MammaPrint(R) Identifies New Subset of Low Risk HER2+ Patients

Huntington Beach, California and Amsterdam (ots/PRNewswire)
--

- Recent Study Reveals Substantial Group of Traditionally
Miscategorized HER2+ Patients

Dr. Michael Knauer from the Netherlands Cancer Institute today
announced data uncovering a substantial group of traditionally
miscategorized low risk HER2+ patients. Agendia's highly accurate
breast cancer tumor recurrence test, MammaPrint(R), was used to
differentiate between patients at high and low risk for recurrence.

HER2+ patients are commonly identified as high risk, yet
MammaPrint was able to identify a low risk subgroup of HER2+
patients, who subsequently experienced a 10 year disease-free
survival of close to 90 percent even in the absence of (neo)adjuvant
trastuzumab (Herceptin(R)) and chemotherapy. Additionally, in a
subgroup of highly endocrine responsive HER2/NEU positive patients,
MammaPrint(R) low risk patients had no relapse.

The results were presented by Dr. Michael Knauer during the 2008
San Antonio Breast Cancer Symposium (SABCS). In the study population
of 169 HER2+ patients MammaPrint(R) classified 16 percent of patients
as having a good prognosis signature with a 10-year distant
disease-free survival (DDFS) of 89 percent, compared to 84 percent of
patients classified as having a poor prognosis signature with a DDFS
of 64 percent.

MammaPrint(R)'s robustness is underscored by the 70 gene panel
unique to the test and a resulting gene profile that covers all
molecular pathways associated with breast cancer.
HER2/NEU-overexpression is observed in 15-20 percent of invasive
breast cancers and is widely considered to be a negative prognostic
factor. As a result, current treatment guidelines classify all
HER2-positive breast cancer patients at high risk of relapse, and
recommend trastuzumab and chemotherapy.

MammaPrint(R) accurately identified a subgroup of patients with a
good clinical outcome in HER2+ early breast cancer. These patients
will be further studied in the ongoing MINDACT-trial (Microarray for
Node-negative and 1-3 positive node Disease may Avoid ChemoTherapy)
to determine the prospects of withholding chemotherapy and/or
trastuzumab in HER2+, MammaPrint(R) low risk patients.

About MammaPrint(R)

MammaPrint(R) is the first 'in vitro diagnostic multivariate
index assay' (IVDMIA) cleared by the U.S. Food and Drug
Administration (FDA). FDA clearance requires clinical and analytical
validation and reporting systems to ensure patient safety issues are
addressed. Highly accurate, MammaPrint(R) identifies patients with
early metastasis--those patients who are likely to develop metastases
within five years following surgery. Several authoritative studies
have shown that chemotherapy particularly reduces early metastasis
risk. In planning treatment, the MammaPrint(R) test result provides a
doctor with a clear rationale to assess the benefit of adjuvant
chemotherapy in addition to other clinical information and pathology
tests.

All MammaPrint(R) tests are conducted in Agendia's CLIA-certified
service laboratory. All other breast cancer recurrence assays
currently marketed have not been subject to the rigorous FDA
clearance process.

About Agendia

Agendia 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 aim to help physicians more accurately tailor cancer
treatments. The company 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
Huntington Beach, California, and in Amsterdam, The Netherlands. For
more information please visit http://www.agendia.com.

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

Contact:
MEDIA CONTACTS: Hans Herklots, Head of Corporate Communications,
Agendia, +31-20-462-1557 Office, +31-620-083-509 Mobile,
hans.herklots@agendia.com; Valerie Delva, Account Executive, Ricochet
Public Relations, +1-212-679-3300 x131 Office, +1-917-975-3191
Mobile, vdelva@ricochetpr.com