MammaPrint(R) Breast Cancer Test Validated in Lymph Node-Positive Breast Cancer Patients
14/12/2007 00:01
PR Newswire
AMSTERDAM, Netherlands, December 13 /PRNewswire/ --
- Results to be presented at San Antonio Breast Cancer Symposium
Agendia BV, world leader in the rapidly evolving field of molecular
diagnostics, announced today that an independent international consortium has
demonstrated the prognostic power of its MammaPrint(R) breast cancer
prognosis test in patients who have 1-3 positive lymph nodes. The data show
that MammaPrint(R) can accurately identify a low risk group of lymph
node-positive breast cancer patients with an excellent survival, implications
that will help doctors to decide the optimal treatment management.
"Lymph node status is considered to be one of the most powerful
prognostic factors for operable breast cancer, with a direct relationship
between the number of positive nodes and disease outcome. However,
approximately 30% of lymph node-positive patients will remain free of distant
metastases without adjuvant chemotherapy," said Dr Laura van 't Veer, chief
research officer at Agendia, who participated in the study. "Identifying
patients with lymph node-positive disease who are at low risk of recurrence
might lead to changes in guidelines for adjuvant chemotherapy."
In the current study, 241 tumor samples from breast cancer patients with
1-3 positive lymph nodes at 2 hospitals were selected and analyzed by the
international TRANSBIG consortium. Patients that were classified as "high
risk" for recurrence using MammaPrint(R) had significantly worse 5- and
10-year survival rates than those that were identified as "low risk." The
numbers indicate that MammaPrint(R) has excellent prognostic power, even in
patients having 1-3 positive lymph nodes. The entire study will be presented
as an oral presentation at the San Antonio Breast Cancer Symposium on
Thursday, December 13 in San Antonio, TX, USA.
"This study is in excellent agreement with our 2002 publication in the
New England Journal of Medicine in which we also found that MammaPrint(R) is
a powerful predictor of disease outcome in lymph node positive breast cancer
patients," said Prof. Dr. Rene Bernards, chief scientific officer at Agendia.
"Based on these data, the inclusion criteria of the large MINDACT clinical
trial using MammaPrint(R) will be enlarged to include patients with 1-3
positive nodes."
Agendia will start offering MammaPrint(R) to patients having 1-3 positive
lymph nodes in Europe. These data will also be submitted to the U.S. Food and
Drug Administration (FDA) for regulatory approval at a later date.
About MammaPrint(R)
MammaPrint(R) laboratory service is the first and only FDA cleared
(February 2007) DNA microarray-based 'in vitro diagnostic multivariate index
assay' (IVDMIA). MammaPrint(R) measures the activity of 70 genes, providing
information about the likelihood of tumor recurrence. The MammaPrint(R) test
measures the level of expression of each of these genes in a sample of a
woman's surgically-removed breast cancer tumor and then uses a specific
formula or algorithm to produce a score that determines whether the patient
is deemed low risk or high risk for spread of the cancer to another site. The
result may help a doctor in planning treatment and appropriate follow-up for
a patient when used with other clinical information and laboratory tests. All
MammaPrint(R) tests are conducted in Agendia's CLIA-certified central service
laboratory.
About Agendia
Agendia, located in Amsterdam, The Netherlands, is a world leader in gene
expression analysis-based diagnostics with three products on the market. The
company focuses on the development and commercialization of diagnostic tests
using tumor gene expression profiling. Agendia was the first company to
receive FDA approval for its breast cancer test -- MammaPrint(R) -- that
predicts the risk of breast cancer recurrence. Its second microarray product,
CupPrint(R)(i), is a diagnostic test to identify the origin of a metastasis
in a cancer type called "Cancer of Unknown Primary." Agendia recently also
presented its new colon cancer prognosis test, ColoPrint(R), which is
currently undergoing further validation. Agendia maintains close ties with
several leading academic centers to develop state of the art diagnostic tests
for cancer. Agendia also offers its expertise to pharma companies focusing on
development of highly effective personalized drugs in the area of oncology.
For more information on Agendia, visit http://www.agendia.com.
(i) CupPrint(R) is based on a license to the TUO database of AviaraDx
EU and non-US Media, Bernhard Sixt, CEO of Agendia, +31-20-512-9161, info@agendia.com; or U.S. Media Contact, Kelly Connor, Vice President of Ogilvy Public Relations Worldwide, +1-212-880-5352, mobile, +1-609-221-5785, Kelly.connor@ogilvypr.com