Agendia's Breast Cancer Test MammaPrint(R) Identifies New Subset Of Low Risk 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.

Agendia