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:8/17/2017)... Village, CA (PRWEB) , ... August 17, 2017 ... ... technology for cancer research and personalized medicine, today announced the launch of a ... Kansas City, Missouri. The study’s goal is to evaluate the potential for early ...
(Date:8/16/2017)... ... 2017 , ... Today, 3Bar Biologics Inc ., the ... funding from an impressive group of investors, including Rev1 Ventures, Maumee Ventures, Ohio ... investment, 3Bar is broadening availability of its groundbreaking offering that uses naturally occurring ...
(Date:8/15/2017)... NC (PRWEB) , ... August 15, 2017 , ... ... 2017, celebrating 10 years of successes helping medical technology companies and inventors develop and ... to a renowned full-service national engineering firm with a portfolio of clients in the ...
(Date:8/15/2017)... , ... August 15, 2017 , ... The Conference ... on Immuno-Oncology 360° (IO360°) programming through a series of upcoming panels and events. The ... 7-9, 2018, at The Roosevelt Hotel in New York City. , “With our experience ...
Breaking Biology Technology:
(Date:4/6/2017)... 2017 Forecasts by Product Type ... by End-Use (Transportation & Logistics, Government & Public Sector, ... Fossil Generation Facility, Nuclear Power), Industrial, Retail, Business Organisation ... Are you looking for a definitive report on the ... ...
(Date:4/3/2017)... 2017  Data captured by IsoCode, IsoPlexis ... a statistically significant association between the potency ... and objective response of cancer patients post-treatment. ... whether cancer patients will respond to CAR-T ... as to improve both pre-infusion potency testing and ...
(Date:3/28/2017)... , March 28, 2017 ... Biometrics), Hardware (Camera, Monitors, Servers, Storage Devices), Software (Video ... and Region - Global Forecast to 2022", published by ... in 2016 and is projected to reach USD 75.64 ... 2017 and 2022. The base year considered for the ...
Breaking Biology News(10 mins):