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."
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
|SOURCE GeneNews Limited|
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