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
'/>"/>

SOURCE Agendia
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

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:1/15/2014)... wearable injector slightly larger than an Oreo cookie may soon ... drugs in the large doses required to treat a wide ... genetic disorders.  An emerging biologic drugs market ... analysts.   Many of these drugs will require a new type ...
(Date:1/14/2014)... BEVERLY HILLS, Calif. , Jan. 14, 2014 The Brandeis ... Los Angeles a premier and affordable laser tattoo ... treatment special. Dr. Brandeis, focus is in providing high quality cosmetic ... to all patients. " Southern California ...
(Date:1/14/2014)... , Jan. 14, 2014   NuAire , a manufacturer of ergonomically ... with Hitachi Koki of Japan ... North America . NuAire will utilize its network of ... Canada to offer assistance in application use, ...
Breaking Medicine Technology:Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2NuAire announces sales and service of Hitachi Koki centrifuges in North America 2
... 1, 2011 Every year thousands of children are hospitalized ... for them. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Teens share ... by colorful pills that look like candy. ... how you can prevent harm by locking your medicine up. ...
... N.J., Nov. 1, 2011 Quest Diagnostics Incorporated (NYSE: ... diagnostic testing, information and services, today announced the CE ... & RSV Direct test on the 3M™ Integrated Cycler. ... uses a proprietary technique to eliminate nucleic-acid sample extraction, ...
Cached Medicine Technology:Quest Diagnostics Announces Launch of Simplexa™ Direct Test for Influenza and Respiratory Viruses in Europe 2Quest Diagnostics Announces Launch of Simplexa™ Direct Test for Influenza and Respiratory Viruses in Europe 3
(Date:4/23/2014)... WEST LAFAYETTE, Ind. - Purdue University researchers have developed ... a living cell by using tiny gold particles with ... Irudayaraj, professor of agricultural and biological engineering, used gold ... material known as BRCA1 messenger RNA splice variants, which ... The number of these mRNA splice variants in a ...
(Date:4/23/2014)... which patients might suffer potentially fatal side-effects from a ... brain scans using pattern recognition software similar to that ... developed by researchers at Imperial College London. Results of ... used the software are published in the journal ... million people each year worldwide. Ischemic strokes are the ...
(Date:4/23/2014)... a country as wealthy as the United States, it may ... not have access to adequate food due to lack of ... , Recent research at the University of Illinois using data ... that the seniors who are dealing with hunger are also ... 8.35 percent of Americans over age 60 faced the threat ...
(Date:4/23/2014)... journal Oncotarget , explored tumour heterogeneity ... own DNA signatures within the same cancer. Such ... targeted treatment strategies. , Firstly they confirmed the ... the KRAS or BRAF mutation. Secondly, they found ... mutation have that specific mutation present uniformly throughout ...
(Date:4/22/2014)... industry leaders visited the New Jersey Institute of ... S. Bloom for the launch of the New ... provides a new model for business innovation through ... assets and investment. U.S. Senator Cory Booker, Panasonic ... Taylor, New Jersey Lieutenant Governor Kim Guadagno, New ...
Breaking Medicine News(10 mins):Health News:Gold nanoparticles help target, quantify breast cancer segments in a living cell 2Health News:Airport security-style technology could help doctors decide on stroke treatment 2Health News:Airport security-style technology could help doctors decide on stroke treatment 3Health News:More Americans in their golden years are going hungry 2Health News:Non-uniform genetic mutations identified in lung cancers could lead to targeted treatment 2Health News:Government and industry leaders herald launch of NJIT's New Jersey Innovation Institute 2
... 3 Yesterday in a historical,and unprecedented move, ... for House Bill 1150 to mandate commercial,insurance companies ... The,bill, introduced by House Speaker Dennis M. O,Brien, ... autism-related treatment for,individuals less than 21 years old., ...
... 3 Mergent, Inc., administrator for the,HealthShares(TM) Indexes, ... Exchange Traded Funds, today announced the following,change effective ... 9, 2008: ISTA,Pharmaceuticals (Nasdaq: ISTA ) will ... Ophthalmology Index. Jerini AG is being,acquired by Shire ...
... Enterprises of,Shijiazhuang, China, the world,s largest manufacturer of vinyl ... notified Medline,Industries, Inc., and other U.S. customers that they ... unable to meet their normal,agreements to customers. Hong Ray ... to supply will have a cost impact on the ...
... Details Support for Community Organizations, SOUTH PORTLAND, ... Shield donated more than $1.4 million to community ... charitable,activities are detailed in the recently released Maine ... found online at, http://www.anthem.com/maine/communityreport ., "All associates ...
... Triple-S,Management Corporation (NYSE: GTS ) today announced that ... quarter ended June 30, 2008,before the market opens on ... Officer, and Juan-Jose Roman, Finance Vice President,and Chief Financial ... and the outlook for the company at 10:00 a.m. ...
... Ro to Promote Circle of Promise ... #401, DALLAS, July 3 , WHAT: Circle of ... Brock (Dr. Ro) will bring the fight against breast cancer to ... their view on breast cancer in the ...
Cached Medicine News:Health News:Pennsylvania Tells Autism Speaks to Stop Talking 2Health News:Mergent, Inc. Announces Changes to the HealthShares(TM) Ophthalmology Index 2Health News:Medline Receives Force Majeure Notice From Hong Ray Enterprises 2Health News:Anthem Blue Cross and Blue Shield Issues Community Report for 2007 2Health News:Triple-S Management Corporation Schedules Second-Quarter Earnings Release and Webcast 2Health News:Susan G. Komen for the Cure(R)'s Circle of Promise to Mobilize African American Women Against Breast Cancer at 2008 Music Festival 2
... is a multi-tasking vacuum source and solvent ... vapor trap and a maintenance-free, oil-free vacuum ... easy-to-use, wide-mouth glass condensation flask collects all ... easy disposal. The UVS400 provides an ideal ...
... Combines BchiVac V-500 with Vacuum Controller ... Electronic switching mechanism turns V-500 on and off ... Compact Housing Model V-500 is a powerful ... applications. Applications Ideally suited for use ...
... membrane vacuum pump designed to handle most vacuum ... use with up to two rotary evaporators ... ovens, concentrators, gel dryers, and filtration apparatuses ... to chemicals and heat load Corrosion-resistant ...
... Universal Vacuum Source is a combination instrument bringing ... 4-headed, Oil-free Vacuum Pump. It is designed to ... abuse., Combines a Refrigerated Cold Trap ... eliminating extra tubing connections. , ...
Medicine Products: