Agendia Publishes Direct Evidence That MammaPrint Predicts Benefit of Chemotherapy in Breast Cancer



    
    Findings Published in Peer-Reviewed Journal, Breast Cancer Research and
    Treatment
    

    HUNTINGTON BEACH, California, and AMSTERDAM, Feb. 18 /CNW/ - Agendia, a
world leader in molecular cancer diagnostics, today announced that a study
demonstrating the direct predictive ability of its breast cancer recurrence
test, MammaPrint(R), has been published in Breast Cancer Research and
Treatment. Additionally, the study authors have been invited to present the
data at the American Association for Cancer Research's 2009 Annual Meeting in
Denver, Colorado.
    "Our multi-study pool of patient data is maturing quickly and this is the
first of a number of forthcoming publications showing MammaPrint's direct
predictive ability for neoadjuvant and adjuvant chemotherapy regimens,"
commented Dr. Bernhard Sixt, Ph.D., President and Chief Executive Officer.
"These findings considerably add to MammaPrint's well-established indirect
predictive evidence for any chemotherapy, since MammaPrint is highly
prognostic for early metastasis risk. Only early metastasis risk can be
reduced by chemotherapy as shown by the Early Breast Cancer Trialists'
Collaborative Group in their most recent 5-year update(*). These new findings
will further support our ongoing discussions with payers and guideline
committees."
    The study directly addresses a major concern expressed in an excellent
review(xx) on the impact of tumor gene expression profiling outcomes in
patients with breast cancer recently published by the Evaluation of Genomic
Applications in Practice and Prevention (EGAPP) Working Group. In its
recommendations EGAPP is particularly concerned by the lack of direct evidence
linking tumor gene expression profiling to improved outcomes. The current
study provides this evidence for MammaPrint and persuasively establishes this
link.

    About the study

    The study was performed in collaboration with the Netherlands Cancer
Institute and analyzed the association between the pathological complete
response (pCR) rate and the results of the MammaPrint(R) test. The achievement
of pCR is a valuable indicator for long-term response in this clinical
setting. A consecutive series of 167 patients who received neoadjuvant
chemotherapy for stage II or III breast cancer was analyzed to assess
MammaPrint's predictive power. 20 percent of the 144 patients in the high risk
group achieved a pCR, whereas none of the patients in the low risk group
achieved a pCR. After a median follow-up of 25 months, 17 relapses were seen
in the high risk group and none in the low risk group. These findings
demonstrate that tumors with a high risk MammaPrint(R) signature are sensitive
to chemotherapy.

    About MammaPrint(R)

    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 risk - 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 chemotherapy in addition to other clinical
information and pathology tests.
    All MammaPrint tests are conducted in Agendia's CLIA-certified service
laboratory. Breast cancer recurrence assays currently marketed by other
manufacturers 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.





For further information:

For further information: 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, (212) 679-3300 x131 Office, (917) 975-3191 Mobile,
vdelva@ricochetpr.com

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