Navigation Links
Agendia Receives New York State Laboratory Permit and Laboratory Accreditation by College of American Pathologists
Date:2/9/2010

HUNTINGTON BEACH, California and AMSTERDAM, February 9 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, announced today that it has received the Clinical Laboratory Permit from the New York State Department of Health. The New York State permit allows the company to receive commercial samples of MammaPrint, its FDA-cleared breast cancer recurrence test.

With this latest permit, Agendia has now obtained all major U.S. clinical laboratory licenses. In addition, the College of American Pathologists (CAP) has accredited Agendia's CLIA regulated laboratory in Huntington Beach, CA.

"The New York State permit is often recognized as one of the most difficult to obtain. Together with our CAP accreditation, CLIA compliance, and FDA-clearance for MammaPrint, we give patients and physicians the confidence they need while making important treatment decisions," said Dr. Bernhard Sixt, Agendia's Chief Executive Officer. "The growing clinical importance of complex genomic testing means that our laboratories need to meet the highest standards of quality for patients and health care professionals."

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 CAP-accredited and CLIA compliant service laboratories. 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©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Medicare Administrator Establishes Reimbursement Coding Policy for Agendias Breast Cancer Recurrence Test MammaPrint(R)
2. Agendia Raises US $23 Million in Series E Financing
3. Agendia Supports Genentechs Citizens Petition Urging FDA to Hold In-Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards
4. Agendia Opens CLIA-Registered U.S. Genomics Laboratory
5. Agendia to Present Multiple Predictive and Prognostic Studies on Breast and Colorectal Cancers at ASCO Annual Meeting
6. Agendia to Present at BioCenturys Future Leaders in the Biotech Industry Conference
7. Agendia Presents Data Supporting MammaPrints Predictive and Prognostic Power at 2009 St. Gallen Breast Cancer Conference
8. Agendia Appoints Seasoned Diagnostics Executive Albert A. Luderer to Supervisory Board
9. Agendia Publishes Direct Evidence That MammaPrint Predicts Benefit of Chemotherapy in Breast Cancer
10. Agendia Appoints VP of Business Development
11. Agendias Breast Cancer Test MammaPrint(R) Standard of Care at Netherlands Cancer Institute - AVL
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... February 10, 2016 Early-career researchers ... Peru , Uganda and ... in health and nutrition   Indonesia , ... and Yemen are being honored for ... They are also celebrated for mentoring young women scientists who are pursuing ...
(Date:2/10/2016)... New York, New York (PRWEB) , ... ... ... Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) today announced that it has joined the ... vaccines and immunotherapies for infectious diseases and cancer. , The Human ...
(Date:2/10/2016)... ... 10, 2016 , ... Benchmark Research, a fully-integrated network of ... long-standing principal investigators (PI) to the roles of Chief Medical Officer, Clinical Research ... Laurence Chu, a Benchmark Research PI in the Austin office, will assume the ...
(Date:2/10/2016)... San Mateo, CA (PRWEB) , ... February 10, ... ... Registry of Multiplex Testing (PROMPT), a research registry built on the secure online ... in September 2014. More than 1,600 participants have joined the PROMPT study, which ...
Breaking Biology Technology:
(Date:2/2/2016)... YORK , Feb. 2, 2016 ... of that Rising Market Are you interested ... analysis forecasts revenues for checkpoint inhibitors. Visiongain,s report ... market, submarket, product and national level. Avoid ... discover what progress, opportunities and revenues those emerging ...
(Date:2/2/2016)... , Feb. 2, 2016  Based on its ... & Sullivan recognizes US-based Intelligent Retinal Imaging Systems ... Sullivan Award for New Product Innovation. IRIS, a ... North America , is poised to ... growing diabetic retinopathy market. The IRIS technology presents ...
(Date:2/1/2016)... Fla. , Feb. 1, 2016  Wocket® smart wallet ( www.wocketwallet.com ... and television personality, Joey Fatone . Las Vegas ... greet fans. --> Las Vegas , where ... --> The new video ad was filmed at the Consumer ... appeared at the Wocket booth to meet and greet fans. ...
Breaking Biology News(10 mins):