GeneNews Receives ISO 13485 Accreditation
TORONTO, CANADA (March 10, 2008):
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 an emerging molecular diagnostics company focused on the application of functional genomics to enable early diagnosis and personalized health management based on disease-specific biomarkers. The Company has a patented core platform technology, the Sentinel Principle®, which has the power 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 launched its first commercial product, ColonSentry™, a blood-based test to pre-screen and assess an individual's risk for colorectal cancer, in Canada in 2008. The company's first US marketing partner, Enzo Clinical Labs, is expected to launch the ColonSentry™ test in New York and New Jersey in the second half of 2010. For more information on GeneNews and ColonSentry™, visit www.genenews.com or www.ColonSentry.com.
Forward-Looking Statements
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.