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:3/27/2021)... ... March 24, 2021 , ... ... Life Sciences and Healthcare firms of all sizes, adds depth to its team ... specialist. Pardillo, who earned his doctorate in computational chemistry from Florida International University ...
(Date:3/27/2021)... ... March 24, 2021 , ... ABI Wellness, ... and reporting approach designed under CEO Mark Watson, today announced a webinar dedicated ... featuring guest speakers Dr. Cameron Clark, Neuropsychologist and Founder of Sharp Thinking, and ...
(Date:3/27/2021)... ... ... The Xtalks editorial team is pleased to announce the launch of the ... joined by editorial team members Ayesha Rashid, Sydney Perelmutter and Mira Nabulsi to discuss ... including insights from industry experts. , The Xtalks Life Science podcast will feature ...
(Date:3/23/2021)... Conn. (PRWEB) , ... March 23, 2021 , ... ... develops solutions for characterizing microbiome populations down to the strain level, recently unveiled ... applications. , Not all microbes are created equal: some are easy to ...
Breaking Biology Technology:
(Date:3/27/2021)... ... March 25, 2021 , ... Phlexglobal announced ... Planet Group, has selected Phlexglobal and its innovative regulatory SaaS software, PhlexSubmission, as ... a comprehensive review of five regulatory software companies, with the review team including ...
(Date:3/27/2021)... ... 25, 2021 , ... The 2021 Virtual Conference on Clinical Trial Supply-Europe ... More and more, clinical trial supply conferences are featuring speakers and forums that ... Asymmetrex’s founder and CEO, James L. Sherley, M.D., Ph.D., presented a talk ...
(Date:3/23/2021)... ... March 23, 2021 , ... G-CON Manufacturing (G-CON), the ... by Matica Biotechnology (Matica Bio), a contract development and manufacturing organization (CDMO) specializing ... the cleanroom build out for its new GMP production facility in College Station, ...
Breaking Biology News(10 mins):