Huntington Beach, California, and Amsterdam (ots/PRNewswire)
- Findings Published in Peer-Reviewed Journal, Breast Cancer
Research and Treatment
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,
"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
The study directly addresses a major concern expressed in an
excellent review** 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.
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.
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 B.V.
Im Internet recherchierbar: http://www.presseportal.ch
MEDIA CONTACTS: Hans Herklots, Head of Corporate Communications,
Agendia, +31-20-462-1557 Office, +31-620-083-509 Mobile,
firstname.lastname@example.org; Valerie Delva, Account Executive, Ricochet
Public Relations, +1-212-679-3300 x131 Office, +1-917-975-3191