NEW YORK (GenomeWeb News) — GeneNews said today it has received certification from the International Organization for Standardization for its Quality Management System, which covers both design and development of in vitro diagnostic test kits that are used in managing colorectal cancer.
Meeting the ISO requirements will help GeneNews gain international regulatory approval for its blood-based molecular diagnostics products, said company CEO Wayne Marshall.
Marshall said that the certification, which was earned after an audit in December 2007 by TUV SUD America, will be an important step in the company’s commercialization strategy.
The company’s first product in development is the ColonSentry, a blood-based biomarker test designed to identify current risk of colorectal cancer. GeneNews said it is using its Sentinel Principle technology in other areas, including cardiovascular disease, arthritis, and neurological disorders.