CE MARKING OF THE DIAGENIC’s BLOOD TEST FOR EARLY BREAST CANCER DIAGNOSIS

DiaGenic ASA today announces the European release of its BCtect® (Breast cancer) blood-based gene-expression assay for clinical diagnostic use. The Breast cancer’s assay is released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices 98/79/EC. BCtect® gene expression test employs an easy to collect blood sample and offers hope for early intervention and treatment. “This CE marking is another major milestone in DiaGenic’s development and constitutes a breakthrough supporting early detection of breast cancer,” says DiaGenic CEO Erik Christensen, MD, PhD. “Early detection is key to survive breast cancer and current diagnostic methods have limitations in their diagnostic accuracy in younger females. The BCtect® is as accurate in premenopausal as in postmenopausal females, and across cancer stages and types. These unique characteristics offers improved early diagnostic capabilities in premenopausal females over current technologies. With its rapid and convenient sample collection BCtect® enables improved breast cancer diagnostics in Europe.” The CE marking of BCtect® follows notice of CE marking of ADtect® (Alzheimer’s disease) on 12 June. Both diagnostic tests will be marketed through a network of distributors in Europe with test analysis performed centrally by DNAVision in Belgium. Contact: MD PhD Erik Christensen, Managing Director Telephone: +47 95939918 e-mail: erik.christensen@diagenic.com