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 met
'/>"/>

SOURCE Agendia B.V.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:5/27/2015)... EAST RUTHERFORD, N.J. , May 27, 2015  Cambrex ... Gregory Sargen , Executive Vice President and Chief Financial Officer, ... June 3, 2015 at 8:00 a.m. EDT in ... webcast and slide presentation can be accessed from the Cambrex ... "Webcasts & Presentations", and a replay will be available for ...
(Date:5/27/2015)... HANOVER, N.J. , May 27, 2015 /PRNewswire/ ... oncology portfolio in 21 medicines and 11 investigational ... the upcoming American Society of Clinical Oncology (ASCO) ... of the European Hematology Association (EHA), June 11-14. ... variety of cancer types, including melanoma, lung, breast, ...
(Date:5/27/2015)... , May 25, 2015 Research and Markets ... the "Research and Future Development Trend Forecast of ... At present, there are 35,600 dialysis centers ... ratio are large due to the different regional operating ... centers in other Asian countries are operated by state-owned ...
Breaking Medicine Technology:Novartis presents new data on 21 medicines and 11 investigational compounds at ASCO and EHA 2Novartis presents new data on 21 medicines and 11 investigational compounds at ASCO and EHA 3Novartis presents new data on 21 medicines and 11 investigational compounds at ASCO and EHA 4Novartis presents new data on 21 medicines and 11 investigational compounds at ASCO and EHA 5Novartis presents new data on 21 medicines and 11 investigational compounds at ASCO and EHA 6Novartis presents new data on 21 medicines and 11 investigational compounds at ASCO and EHA 7Novartis presents new data on 21 medicines and 11 investigational compounds at ASCO and EHA 8China Dialysis Market Report: Research and Future Development Trends and Forecasts 2015-2020 2
... the Consumer Healthcare Products Association (CHPA), announced Tammy Walsh as ... campaign to raise awareness of teen cough medicine ... boys and a high school math teacher from Northport, N.Y., ... substance abuse. Millions of Americans use medicines ...
... Dec. 15, 2011 Intellect Neurosciences, Inc. (OTCBB: ... and development of disease-modifying therapeutic agents for the ... today that it has filed an appeal regarding ... (EPO) to revoke the company,s ANTISENILIN® patents. The ...
Cached Medicine Technology:CHPA's Five Moms Campaign to Stop Medicine Abuse Welcomes New Mom Tammy Walsh 2CHPA's Five Moms Campaign to Stop Medicine Abuse Welcomes New Mom Tammy Walsh 3Intellect Neurosciences Files Appeal in Europe in Response to Opposition Proceedings Instituted by Elan Pharmaceuticals and Wyeth/Pfizer 2Intellect Neurosciences Files Appeal in Europe in Response to Opposition Proceedings Instituted by Elan Pharmaceuticals and Wyeth/Pfizer 3
(Date:5/27/2015)... (PRWEB) May 27, 2015 Coco Libre announced ... be able to reach for Organic Coconut Water to quench ... will be available at VIP areas, artist greenrooms, corporate skyboxes ... available at area hotels and on festival shuttle buses. ... this year,” said Noa Elan, Director of Strategic Partnerships for ...
(Date:5/27/2015)... Cincinnati Veterans Affairs Women’s Health Clinic in ... Foundation is proud to host the first annual Women Veterans ... 11 at the Freedom Center from 6 p.m. to 10 ... emcee. , This event honors and celebrates women tri-state ... The banquet is free to the first 150 women Veterans ...
(Date:5/27/2015)... Arizona (PRWEB) May 27, 2015 Genius ... of their advanced programmatic marketing technology, they have boosted ... advertising support on a regional level for seven Utah-based ... marketing was through television and radio media. In 2014 ... with the help of Genius Monkey , shifted ...
(Date:5/27/2015)... (PRWEB) May 27, 2015 With InnerVoice ... communication environment where the message is not only heard but ... drawing, or virtually any motivating image. This award-winning and affordable ... offer. , Now, using InnerVoice Sender app ... be sent to a learner remotely for no additional cost. ...
(Date:5/27/2015)... With a prevalently high rate of ... the "ACA - Controlling the Chaos" webinar revealed that, ... in the process of researching ACA solution options ... for the reporting mandates. , According to a sample ... who are currently vetting ACA reporting solutions are on ...
Breaking Medicine News(10 mins):Health News:Coco Libre Puts Organic Coconut Water on the Line-up at BottleRock Napa 2Health News:Cincinnati VA Women’s Health Clinic Celebrates Women Veterans at Awards Banquet 2Health News:Genius Monkey Boosts Utah Honda Dealers Website Traffic 142% 2Health News:Newly Released: InnerVoice Sender App Ups the Ante in Communication Technology for Autism with Remote Prompting 2Health News:Newly Released: InnerVoice Sender App Ups the Ante in Communication Technology for Autism with Remote Prompting 3Health News:Newly Released: InnerVoice Sender App Ups the Ante in Communication Technology for Autism with Remote Prompting 4Health News:Employers are On Track for ACA Reporting According to Businessolver Poll 2
... but also helps strengthen them, according to research//. ... interference (competing information). Forty-eight people between the ages of ... had normal, healthy sleep routines and were not taking ... wake group without interference, a wake group with interference, ...
... says targeting smaller lesions does little to significantly reduce ... results in extremely high// financial costs and a large ... the low malignancy rate among so-called diminutive polyps gives ... greater the best estimated value per life year gained ...
... sufferers are usually treated with the drug called levodopa ... prolonged use of the drug, many patients may experience ... ,Parkinson's disease is a slow process of ... levels fall, the symptoms of Parkinson’s shows up as ...
... the menopausal transition experience hot flashes: unpredictable, sometimes disruptive, ... and face. Although generations of physicians have prescribed hormones ... on the underlying causes of hot flashes. ,Three ... alcohol consumption in contributing to – or lessening – ...
... Cancer Center have zeroed in on a crucial gene, ... breast cancer and resistance// to long-term estrogen deprivation. The ... of breast cancer reappearance, and would enable a good ... ,The research targeted breast cancer cells which ...
... two genes could determine the vulnerability of the elderly to ... ,Age-related macular degeneration (AMD) is a disease associated ... is needed for seeing objects clearly and for common daily ... affects the macula, the part of the eye that allows ...
Cached Medicine News:Health News:Sleep Makes Your Memory Strong 2Health News:Virtual Colonoscopy is Most-effective for Screening Colon Cancer 2Health News:Hot Flashes: Studies Explore the Various Possibilities Involved 2Health News:Hot Flashes: Studies Explore the Various Possibilities Involved 3Health News:Genes Responsible for a Blinding Condition Identified 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: