Navigation Links
FDA Broadens Clearance for Agendia's MammaPrint(R)
Date:12/17/2009

HUNTINGTON BEACH, California and AMSTERDAM, December 17 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, announced today that the US Food and Drug Administration (FDA) cleared its MammaPrint breast cancer recurrence test for all ages. MammaPrint is the only FDA-cleared breast cancer recurrence test available to patients and physicians. Over the past three years, the FDA has issued four clearances for MammaPrint, covering all aspects of this important service.

"This FDA clearance, along with our recently obtained CMS coverage for all stage I and II breast cancer patients, including patients with up to three positive lymph nodes, will facilitate our discussions with healthcare providers about patients' eligibility criteria for MammaPrint," said Dr. Bernhard Sixt, Agendia's Chief Executive Officer.

"This new clearance confirms the opinion of the international medical community that MammaPrint carries clinical utility and is safe and effective in breast cancer patients of all ages," said Dr. Richard Bender, Chief Medical Officer of Agendia. "Seeking clearance for all ages further demonstrates Agendia's commitment to provide patients and physicians with high quality FDA-cleared tests to help guide vital treatment decisions." In Europe, MammaPrint has been approved for all ages since 2004.

About MammaPrint(R)

MammaPrint is the first and only breast cancer recurrence test cleared by the U.S. Food and Drug Administration (FDA).FDA clearance under the in vitro diagnostic multivariate index assay (IVDMIA) guidelines requires clinical and analytical validation and reporting systems to ensure patient safety issues are addressed. Highly accurate, MammaPrint identifies patients with early metastasis risk - 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 results provide doctors 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-accredited service laboratory. Breast cancer recurrence assays currently marketed by other manufacturers have not been subject to the rigorous FDA clearance process.

About Agendia

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 help physicians more accurately tailor cancer treatments. Agendia 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.

SOURCE Agendia B.V.


'/>"/>
SOURCE Agendia B.V.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture
2. Semafore Broadens Pipeline With Multi-Targeted Kinase Inhibitors
3. BrainCells Inc. Broadens Scientific Advisory Board Adding Drs. Edward Scolnick and David Holtzman
4. SIRO Clinpharm Collaborates with Mediscis, Broadens Early Phase Drug Development Expertise
5. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
6. Instrumentation Laboratory Receives FDA Clearance for HemosIL RecombiPlasTin 2G Assay
7. Rcadias COR Analyzer Family of Products Receives Second FDA Clearance
8. Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance
9. BD Announces FDA 510(k) Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Blood Cultures
10. Kingfisher Announces FDA 510(k) Clearance of Breakthrough KFH Energy for Chronic Pain Sufferers
11. Thermo Fisher Scientific Receives FDA Clearance for MRSA Test Medium
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... , April 28, 2016  ValGenesis, Inc., ... Management Solutions (VLMS) today announced that a ... for sufferers of chronic kidney failure has ... manage their corporate validation process. The global ... software solution to manage their validation processes ...
(Date:4/27/2016)...   , ... le trimestre, soutenu par une croissance de +42% ... de +16% des ventes aux hôpitaux et cliniques  ... (Euronext : MKEA, FR0010609263 ; OTCQX : MKEAY), inventeur de Cellvizio®, ... chiffre d,affaires pour le premier trimestre clos au ...
(Date:4/27/2016)... DELHI , April 27, 2016 ... CSR initiative to save newborns   ... hospital for women & newborns in collaboration with Breast Milk ... launched the first Pasteurized Human Milk Bank, ,Amaara, in Delhi-NCR ... best nutritional food source for infants and should be available ...
Breaking Medicine Technology:
(Date:4/28/2016)... ... April 28, 2016 , ... Horizon Blue ... with doctors and hospitals to make transformative changes in how health care is ... minds this week in discussing breakthroughs in cellular medicine to treat disease. After ...
(Date:4/28/2016)... ... April 28, 2016 , ... Cognizin® Citicoline is one ... Nominated in the Healthy Ageing category, Cognizin® is being considered for this prestigious ... division can include everything from antioxidants, lipids, proteins, and botanicals. NutraIngredients will choose ...
(Date:4/28/2016)... ... April 28, 2016 , ... Amada Senior Care, premier provider of non-medical in-home ... – its San Antonio West location. Prior to entering the senior care industry, Amada ... opening of Amada San Antonio West will take place on Friday, April 29th. ...
(Date:4/28/2016)... ... April 28, 2016 , ... ... Surgery Education and Anzu®, developers of the AnzuMedical™ Knowledge Sharing and Collaboration ... Collaborative Residency Network. The platform is scheduled to launch in July 2016 and ...
(Date:4/28/2016)... ... April 28, 2016 , ... Point ... miniature microphones and headsets announced today that the US Patent Office has approved ... into a structure. This innovative design creates a lightweight and modular audio headset ...
Breaking Medicine News(10 mins):