Agendia's MammaPrint(R) Predicts Response To Neoadjuvant Chemotherapy In Breast Cancer

Agendia, a world leader in molecular cancer diagnostics, today
announced MammaPrint(R)'s ability to predict response to neoadjuvant
chemotherapy in breast cancer.





В В В  Dr. Laura van 't Veer, from the Netherlands Cancer Institute,
presented the data at the 2008 San Antonio Breast Cancer Symposium (SABCS)
during the session Molecular profiling for guiding therapeutic decisions. The
study analyzed the association between the pathological complete response
(pCR) rate and the results of the MammaPrint test.





В В В  "Physicians are increasingly supportive of MammaPrint in
clinical practice because they believe it provides them with invaluable
information for patient treatment planning. MammaPrint's ability to
accurately determine high risk patient responsiveness to chemotherapy both
confirm and speak to the confidence physicians express in this
state-of-the-art genomic breast cancer test," commented Dr. Richard Bender,
Chief Medical Officer of Agendia and a life-long practicing oncologist who
made a career at the NCI, Kaiser Permanente and Quest Diagnostics.





В В В  Findings in the neoadjuvant setting support MammaPrint's
predictive power for chemotherapy response, in addition to its previously
demonstrated prognostic value for early stage disease. The achievement of pCR
is a valuable indicator for long-term response in this clinical setting.





В В В  A consecutive series of 167 patients who received neoadjuvant
chemotherapy for stage II or III breast cancer were analyzed to assess
MammaPrint's potential predictive power. 20 percent of the 144 patients in
the poor prognosis signature group achieved a pCR, whereas none of the
patients with a good prognosis signature achieved a pCR. After a median
follow-up of 25 months, 19 relapses were seen in the poor signature and none
in the good signature group. These findings suggest tumors with a poor
prognosis MammaPrint signature are sensitive to chemotherapy.





В В В  About MammaPrint(R)





В В В  MammaPrint 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 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 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.





В В В  All MammaPrint 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.





В В В  About Agendia





В В В  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