FDA grants Breakthrough Device Designation for Roche ' s Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma

Basel, 4 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys ® GALAD score.* This algorithmic score combines gender and age with the biomarker results of the Elecsys AFP, AFP-L3 and PIVKA-II and is intended to aid diagnosis of early stage hepatocellular carcinoma (HCC). Dr. Amit Singal, Medical Director of the Liver Tumor Program   and Clinical Chief of Pathology at UT Southwestern Medical Center in Dallas, USA, stated, " HCC is the fourth leading cause of cancer-related death worldwide, with the highest burden of disease in East Asia and Africa. This high mortality is largely driven by most patients being detected at a late stage, when curative therapies are no longer possible. Therefore, improving early HCC detection is a critical area of need. "
Source: Roche Media News - Category: Pharmaceuticals Source Type: news