Navigation Links
GeneNews receives ISO 13485 accreditation
Date:3/11/2008

TORONTO, March 11 /PRNewswire-FirstCall/ - GeneNews Limited (TSX: GEN), a company focused on developing molecular diagnostic tests derived from a simple blood sample for the early detection of diseases and personalized health management, today announced that its Quality Management System, which covers the design and development of in-vitro diagnostic (IVD) test kits used in the management of colorectal disease status in a laboratory setting, has met the requirements of the ISO 13485:2003 standard. This certification was obtained following a successful audit in December 2007 by TUV SUD AMERICA INC.

"The implementation of our quality management system has established a solid foundation that will facilitate regulatory approval of our products on a global basis," said K. Wayne Marshall, MD, PhD, President and Chief Executive Officer of GeneNews. "This ISO accreditation reflects our commitment to quality and is an important milestone in the commercialization strategy for our products."

About GeneNews

--------------

GeneNews is focused on the application of functional genomics to enable early diagnosis and personalized therapeutic intervention based on disease-specific biomarkers. The Company has developed a novel approach, the Sentinel Principle(TM), to detect and stage virtually any disease or medical condition from a simple blood sample. GeneNews is currently applying the Sentinel Principle in major areas with unmet clinical needs such as cancer, arthritis, cardiovascular disease and neurological disorders. GeneNews' first product in development, ColonSentry, is a convenient and patient-friendly blood-based biomarker test that can identify the current risk of colorectal cancer. For more information on GeneNews, visit http://www.genenews.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.


'/>"/>
SOURCE GeneNews Limited
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. GeneNews initiates patient sample accrual for validation studies of colon cancer blood test
2. GeneNews Chief Scientist Dr. C.C. Liew co-editor of new genomics reference book
3. GeneNews CSO Dr. CC Liew awarded state honour by the Government of Malaysia
4. Advanced Life Sciences Receives Nasdaq Notification
5. ActivBiotics Receives FDA Orphan Drug Designation for Superoxide Dismutase Mimetic, M40403, in Oral Mucositis of Cancer
6. New 300mg Loading Dose Tablet for Plavix(R) Receives Positive Opinion From the European Committee for Medicinal Products (CHMP)
7. Osteotech Receives FDA Clearance for Plexur M(TM) Biocomposite
8. Ventria Receives Friends of Education Award From Geary County School District
9. STAAR Surgical Receives Approval to Market Visian(R) Toric Implantable Collamer Lens in China
10. Actavis Receives Approval for Irinotecan Hydrochloride Injection; Extends US Portfolio with First Injectable Product
11. Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/11/2017)... ... January 11, 2017 , ... Phase 1 clinical trial ... of the investigational anti-cancer agent tucatinib (formerly ONT-380) against HER2+ breast cancer. The ... percent of these heavily pretreated patients saw clinical benefit from the drug, with ...
(Date:1/11/2017)... , ... January 11, 2017 , ... ... year and costing healthcare systems more than $23.7 billion, healthcare systems are ... , Among the most common sepsis-causing pathogens are bacteria and the yeast ...
(Date:1/11/2017)... ... January 11, 2017 , ... ... announced today that the National Science Foundation (NSF) has awarded Symbios a ... will be used to commercialize the Symbios Tubular Plasma Reactor™ (TPR™) by scaling ...
(Date:1/11/2017)... , Jan. 11, 2017  GenVec, Inc. ... delivery company, announced today that its chief scientific ... a talk entitled  "AdenoVerse™ platform for translational development ... Biotech Showcase at the upcoming Phacilitate Cell & ... Miami , Florida.  Dr. Brough,s presentation will ...
Breaking Biology Technology:
(Date:1/3/2017)... VEGAS , Jan. 3, 2017 Onitor, ... the introduction of Onitor Track, an innovative biometric data-driven ... men, showcasing this month at the 2017 Consumer Electronics ... In the U.S., the World Health ... more than two-thirds of adults who are overweight or ...
(Date:12/22/2016)... , December 22, 2016 SuperCom ... of secure solutions for the e-Government, Public Safety, HealthCare, and Finance ... of SuperCom, has been selected to implement and deploy a community-based ... Northern California , further expanding its presence in ... This ...
(Date:12/20/2016)... N.C. and GENEVA, Dec, 20, 2016 /PRNewswire/ ... biometric data sensor technology, and STMicroelectronics ... the spectrum of electronics applications, announced today the ... development kit for biometric wearables that includes ST,s ... with Valencell,s Benchmark™ biometric sensor system. ...
Breaking Biology News(10 mins):