Navigation Links
MammaPrint(R) Breast Cancer Test Shown To Be Powerful Tool for Prognosis Prediction in Postmenopausal Breast Cancer Patients
Date:12/17/2007

Agendia to file for expanded FDA clearance for MammaPrint(R)

AMSTERDAM, Netherlands, Dec. 17 /PRNewswire/ -- Agendia BV, world leader in the rapidly evolving field of molecular diagnostics, announced today that its MammaPrint(R) breast cancer prognosis test was shown to be a valuable tool to assess risk of breast cancer recurrence also in postmenopausal breast cancer patients. Data recently presented at the AACR/NCI/ EORTC conference "Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications" in San Francisco showed that MammaPrint is a valuable tool to assess risk of breast cancer recurrence in older age breast cancer patients as well.

To date, MammaPrint has received two clearances from the Food and Drug Administration (FDA) for its test. The first clearance in February of this year cleared MammaPrint for safety and effectiveness under the In Vitro Diagnostic Multivariate Index Assay (IVDMIA) Guidelines for use in breast cancer prognosis. In June, Agendia received a second clearance for the test in conjunction with RNARetain(R)*, an RNA stabilizing solution allowing shipping of tumor biopsies at ambient temperature, greatly facilitating the logistical process of sample handling. FDA clearance also ensures the validity of the RNA integrity chain from patient to result, which ensures that the whole test procedure is fit for daily clinical settings. With the new data, Agendia will seek additional clearance from the FDA for its MammaPrint breast cancer prognosis test to include patients over age 60.

In the underlying study, breast tumors from 100 patients with lymph node- negative, invasive breast cancer (median age 62 years, but also including elderly patients over age 75) who were diagnosed and treated at the Massachusetts General Hospital in Boston, USA between 1985 and 1997 were subjected to MammaPrint gene expression analysis. MammaPrint, having a digital readout, classified patients as being at either low or high risk for distant metastasis and the results were compared to actual outcome of disease in these patients. The results of the study confirm that MammaPrint is also a very powerful tool to identify older breast cancer patients at low risk for metastatic disease. The results of this study have been submitted for publication to one of the major clinical research journals.

"We are very pleased with this new validation study," says Bernhard Sixt, chief executive officer (CEO) of Agendia. "MammaPrint is now independently validated for both premenopausal and postmenopausal women, an important and necessary validation considering that breast cancer biology between the two groups is different. We are confident that we now have enough data to seek clearance from the FDA for use of this test in breast cancer patients of all ages."

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 measures the activity of 70 genes, providing information about the likelihood of tumor recurrence. The MammaPrint 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 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)*, 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 profile, 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.

* RNARetain(R) is a trademark of Asuragen Inc.

* CupPrint(R) is based on a license to the TUO database of AviaraDx


'/>"/>
SOURCE Agendia BV
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Agendias MammaPrint(R), the Only FDA-Cleared Breast Cancer Prognosis Test, is Now Widely Available to U.S. Patients
2. Study Shows MammaPrint(R) Breast Cancer Test Provides Benefits to Patients from Personalized Treatment Regimen
3. Survival differences by race most apparent in advanced stages of breast cancer
4. MRI finds breast cancer before it becomes dangerous
5. Pathway links inflammation, angiogenesis and breast cancer
6. Drop in breast cancer incidence linked to hormone use, not mammograms
7. Breast cancer prevention practices vary across Canada
8. Eating junk food whilst pregnant and breastfeeding may lead to obese offspring
9. Acrylamide Wont Raise Breast Cancer Risk
10. New link between estrogen and breast cancer
11. Hypnosis Eases Pain of Breast Cancer Surgery
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/18/2017)... ... August 18, 2017 , ... Mediaplanet today announces the ... healthy lifestyles and highlighting the importance of proactive eye and ear health. The ... the latest innovations in hearing aid technology. , In this issue, the ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... and financial consultations to communities throughout the greater DC region, is inaugurating a ... goal of rescuing local animals and training them to be companions for veterans ...
(Date:8/18/2017)... ... 2017 , ... MLM Insurance Group, a Miami area provider ... is working to support the Take Stock In Children Foundation during a regional ... The Take Stock In Children Foundation (TSC) offers guidance and assistance to low ...
(Date:8/18/2017)... , ... August 18, 2017 , ... The Golseth Agency, ... the Dallas/Fort Worth area, is spearheading a regional charity campaign organized to provide support ... In early June of this year, Christina and her children returned from out of ...
(Date:8/18/2017)... , ... August 18, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... will lift the veil on false teachings pertaining to the mother of the Savior whom ... you see a far different picture of the role of this historical woman. , ...
Breaking Medicine News(10 mins):
(Date:8/3/2017)...  Opioid addiction and other drugs of abuse, blood ... threatening outcomes, were problems taken on directly as laboratory ... support them, met this week. This according to Kalorama ... of abuse, procalcitonin and acute kidney injury were key ... meeting in San Diego, CA. ...
(Date:8/2/2017)... , Aug. 2, 2017  Life Flight Network and PeaceHealth ... agreement improves patient care and operational efficiency for patients at ... , Cottage Grove , and ... transportation. PeaceHealth and Life Flight Network work collaboratively to move ... transport, or when a time sensitive emergency exists. ...
(Date:7/31/2017)... -- Diplomat Pharmacy, Inc. (NYSE: DPLO), has been named one of ... by Crain,s Detroit Business . The annual Crain,s ... revenue growth. This year,s edition measures growth from 2013 to ... complete list, visit crainsdetroit.com/awards/fast_50/2017 .  "Being ... Phil Hagerman , CEO and chairman of Diplomat. "We,ve ...
Breaking Medicine Technology: