Navigation Links
Agendia Earns ISO Certification for Facilities in Amsterdam and Irvine
Date:8/20/2012

IRVINE, Calif. and AMSTERDAM, Aug. 20, 2012 /PRNewswire/ -- Agendia, an innovative molecular cancer diagnostics company and leader in personalized medicine, today announced that it has been granted the International Organization for Standardization (ISO) 13485 certification for all activities at their facilities in Irvine and Amsterdam. Agendia has been a leader in maintaining the highest quality standards and operating in compliance with FDA GMP QSR, CLIA, CAP, OSHA and the CE Mark as well as requirements for all 50 states in the US.

Agendia's breast cancer Symphony suite consists of unique FFPE tissue tests that provide vital genomic information to support complex breast cancer treatment decisions. As the globally recognized quality control certification for medical devices and related services, receipt of ISO 13485 certification confirms that the execution of Agendia's Symphony diagnostic services, including MammaPrint®, BluePrint™, TargetPrint® and TheraPrint®, meet the highest internationally recognized quality standards. In addition, the certification affirms that the design and development of all of Agendia's current and future diagnostic services are of the highest quality.  

"Agendia is committed to developing clinically useful diagnostic tests that provide clear and accurate results.  Part of this commitment is ensuring that our products and facilities comply with the most rigorous quality standards," said David Macdonald, CEO of Agendia. "In addition to the FDA clearances for our products, ISO certification provides patients and physicians with the confidence that Agendia's diagnostic tests provide safe, effective, reliable and actionable information." 

The ISO 13485 quality standard specifies requirements for a quality management system to demonstrate its ability to consistently meet customer and regulatory requirements. The primary objective of ISO 13485 is to harmonize regulatory requirements for quality management systems globally and includes an emphasis on process control and effectiveness for; design, development, manufacture, risk management, and distribution of related medical services.

About Agendia:
Agendia is a leading molecular diagnostic company that develops and markets genomic-based diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer Symphony™ suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients.  Symphony includes MammaPrint, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint­­, a molecular subtyping assay, TargetPrint®, an ER/PR/HER2 expression assay, and TheraPrint®, an alternative therapy selection assay. Together, these tests help physicians determine a patient's individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials.

For more information, please visit www.agendia.com.

For further information, please contact:

Post+Beam
Melissa Hurley
Tel: +1 646 442 2773
E-mail: hurley@postandbeam.is


'/>"/>
SOURCE Agendia
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Agendia Names Industry Veteran Glen Fredenberg CFO and Vice President of Finance
2. Agendia Announces Nine Studies in Breast and Colon Cancer for Presentation at 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO)
3. Cardiac Science Earns Top Marks for Cardiac Stress Test, Telemetry Monitor Systems
4. ZirMeds SaaS Solution Earns EHNAC HNAP Certification
5. Arkansas Prostate Cancer Center Earns High Honor of ACR-ASTRO Accreditation
6. Neusoft Positron Medical Systems Receives ISO Certification and CE Mark for their Attrius PET System
7. Plainfield Precision Achieves ISO 13485:2003 Quality Management Certification for Medical Device Manufacturing
8. New Specialty Pharmacy Certification Board to Certify Specialty Pharmacists
9. Integrity Life Sciences Receives CE Mark and ISO Certifications for the Integrity Spinal Care System Medical Device
10. Attorneys for Class of Female VPs and SVPs Employed by PR Giant MSLGroup Clarify Companys Inaccurate Description of Federal Courts Recent Certification Ruling
11. NeuroSigma Receives Global Quality Control Certification
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/31/2016)... , May 31, 2016 The ... is progressing at a CAGR of 10.6% within a ... valued at US$0.46 bn in 2013. Owing to favorable ... to reach US$0.88 bn by the end of this ... from the market,s holistic representation in a research report ...
(Date:5/31/2016)... ZIONA, Israel , May 31, ... medicine company utilizing its proprietary plant-based rhCollagen technology for ... authorization from the Chief Scientist of Israel,s ... of its NIS 12 million development project for 2016. The ... higher than last year,s authorized grant, which totaled NIS ...
(Date:5/30/2016)... India , May 30, 2016 /PRNewswire/ ... market research report "Healthcare Biometrics Market by ... (Signature, Voice)), Multifactor, Multimodal), Application (Workforce Management), ... Forecast to 2021", published by MarketsandMarkets, the ... Million by 2021 from USD 1,182.6 Million ...
Breaking Medicine Technology:
(Date:5/31/2016)... ... May 31, 2016 , ... Twenty years ago it was revolutionary: ... trying to silence the voices they hear. But this approach has proven transformative, both ... method has steadily gained credibility and now is used around the world, but it ...
(Date:5/31/2016)... Eden Prairie, MN (PRWEB) , ... May 31, 2016 , ... ... accreditation from the American Association for Laboratory Accreditation (A2LA) to include ISO 594-1 and ... the most common means of achieving a leak-free connection between two medical devices (e.g. ...
(Date:5/31/2016)... ... May 31, 2016 , ... Effective leaders not only drive service ... as a whole. On June 2, Northbound CEO Mike Neatherton and COO Paul Alexander ... presenting the opening plenary on “Leadership: The Journey to Authenticity” with Onsite Workshops CEO ...
(Date:5/31/2016)... ... ... The Global Wellness Summit (GWS), an annual conference for international leaders ... spa and beauty in Europe. The organization asked its partner experts in Europe - ... - to forecast where wellness is headed in Europe. Predictions range from European nations ...
(Date:5/31/2016)... Montana (PRWEB) , ... May 31, 2016 , ... Spectrum ... Lift. This new lift has been designed and built with the user in mind. ... of aquatic consultants have informed us that an ADA 400 lbs lift is a ...
Breaking Medicine News(10 mins):