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

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

* 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:
(Date:11/28/2015)... (PRWEB) , ... November 28, 2015 , ... Beginning November 30th at 6:00 a.m. EST ... the most savings. , With possible savings of up to 20% off orders $80 or ... homepage of the website every few hours. , As a competitive e-commerce website for skin ...
(Date:11/27/2015)... ... November 28, 2015 , ... There is only one major question facing ... last year? , This question has not been an easy question to answer. Especially ... age and the younger workforce don’t share the same discipline around working long hours. ...
(Date:11/27/2015)... , ... November 27, 2015 , ... According to an ... by the University of Toronto and the University of British Columbia suggested that laws ... head injuries. The article explains that part of the reason for the controversial conclusion ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... the health care in America. As people age, more care is needed, especially ... are rising, and medical professionals are being overworked. The forgotten part of this ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, from ... dispense prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. , ... prescription medications. In doing so, it could help to prevent potential overdose situations. ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , 26 november 2015 AAIPharma ... de geplande investering aan van ten minste ... laboratoria en het mondiale hoofdkantoor in ... zal resulteren in extra kantoorruimte en extra ... de groeiende behoeften van de farmaceutische en ...
(Date:11/26/2015)... November 26, 2015 ... nieuwe aanpak combineert immunotherapie met Bremachlorin-photodynamische therapie ... ) --> ... (Photo: ) ... Medisch Centrum (LUMC) blijkt ...
(Date:11/26/2015)... 2015 Research and Markets ( ) has ... Market Outlook to 2019 - Rise in Cardiac Disorders and ... report to their offering. Boston ... scientific and others. --> The ... Boston scientific and others. ...
Breaking Medicine Technology: