Navigation Links
Agendia's MammaPrint(R), the Only FDA-Cleared Breast Cancer Prognosis Test, is Now Widely Available to U.S. Patients
Date:12/12/2007

AMSTERDAM, The Netherlands, Dec. 12 /PRNewswire/ -- Agendia makes its breast cancer prognosis test, MammaPrint(R), available to U.S. patients after receiving two clearances from the Food and Drug Administration (FDA) for its test. The first clearance in February of this year cleared MammaPrint(R) as an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) for use in breast cancer prognosis. In June of this year, 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.

"We are very pleased to make MammaPrint widely available to U.S. patients and their physicians," said Bernhard Sixt, chief executive officer and co-founder of Agendia. "We believe it will play an important role in patients' course of treatment, and Agendia is seriously committed to educating the marketplace about the superior aspects of this diagnostic tool, which has broader indications and clearer results over other available options."

Dr. Neal S. Goldstein, MD, Director, Molecular Oncology and Advanced Diagnostics Laboratory of William Beaumont Hospital in Royal Oaks, Michigan says, "I prefer MammaPrint(R) because it is applicable for both ER positive and ER negative breast cancers as there is no standard determining the ER status. In addition, MammaPrint(R) encompasses many genes and, as cancers are complex, the clinical utility of assays using smaller numbers of genes is dubious in my opinion."

Agendia's Chief Operating Officer Dr. Jan Groen says, "The University of California at San Francisco (UCSF) Medical Center at Mount Zion and the Dan L. Duncan Cancer Center at Baylor College of Medicine in Houston, Texas were the first two reference centers in the U.S. to offer the test to patients. We expect to announce additional centers by the end of the year."

About MammaPrint(R)

MammaPrint(R) is a DNA micro array-based in vitro diagnostic laboratory service that 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 a distant site (metastasis). The result may help a doctor in planning appropriate follow-up for a patient when used with other clinical and pathological information.

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 commercialize a prognostic test -- MammaPrint(R) -- that predicts the risk of breast cancer recurrence. 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.


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

Related medicine news :

1. Survival differences by race most apparent in advanced stages of breast cancer
2. MRI finds breast cancer before it becomes dangerous
3. Pathway links inflammation, angiogenesis and breast cancer
4. Drop in breast cancer incidence linked to hormone use, not mammograms
5. Breast cancer prevention practices vary across Canada
6. Eating junk food whilst pregnant and breastfeeding may lead to obese offspring
7. Acrylamide Wont Raise Breast Cancer Risk
8. New link between estrogen and breast cancer
9. Hypnosis Eases Pain of Breast Cancer Surgery
10. Discovery suggests location of genes for breast density, a strong risk factor for breast cancer
11. Longaberger Expands Horizon of Hope Campaign to Build Support for American Cancer Societys Breast Cancer Initiatives
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/27/2017)... ... July 27, 2017 , ... Standard Process is ushering in a new era ... North Carolina Research Campus (NCRC) in Kannapolis, North Carolina and by announcing a new ... fall of this year, occupying over 10,000 square feet on the first floor of ...
(Date:7/27/2017)... CA (PRWEB) , ... July 27, 2017 , ... ... the addition of a secure cloud-based polysomnography (PSG) distributed scoring solution to its ... accelerated diagnostics and sleep care management. The speed and functionality of scoring in ...
(Date:7/27/2017)... ... ... isn’t always easy. Currently, more than 80 percent of Americans fail to eat the recommended ... sugar. This trend may help explain why the obesity rate seems stuck. The most recent ... culture, we seem to have food on the brain more. "We eat two more large ...
(Date:7/27/2017)... ... 27, 2017 , ... HIMSS announced today that Michael Daniel, ... the HIMSS Healthcare Security Forum, the nation’s foremost event for health organizations tackling ... 2017. , Daniel will deliver his keynote, The Evolving Healthcare Information Security Organization, ...
(Date:7/26/2017)... (PRWEB) , ... July 26, 2017 , ... ... Talent Management Solutions as part of their continued efforts to provide innovative offerings ... develop the best IT resources and build dynamic, high-performing teams to address healthcare ...
Breaking Medicine News(10 mins):
(Date:7/11/2017)... Research Corp., also known as ,The Epigenetics Company, announced today the release ... manner using the myDNAge ™ test. Based on Horvath,s Clock, so ... and biostatistics at the David Geffen School of Medicine at UCLA ... DNAge ™ technology is used to analyze DNA methylation patterns of ... ...
(Date:7/11/2017)...  Sysmex America, Inc., a leading provider of ... well as middleware information systems technology, today announced ... assurance easier and more risk free than manual ... the innovation that it delivers to the laboratory. ... processes to a new level with automated, continuous ...
(Date:7/10/2017)... , July 10, 2017  US medical equipment ... in 2021, according to Medical Equipment & ... by Freedonia Focus Reports. Continued increases in demand for ... aging of the population and supported by gains in ... equipment and supplies. New product introductions will also drive ...
Breaking Medicine Technology: