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. " The Elecsys GALAD score will be the first GALAD score, with regulatory approval, for use in In Vitro Diagnostics and is an integral part of the Roche Diagnostics Liver Indication Program, which aims to improve diagnostic workflows throughout chronic liver disease management. Combined with ultrasound, the Elecsys GALAD score has the potential to support clinicians by giving them more accurate information at an earlier stage, thus improving patient outcomes while being minimally invasive for people and potentially also more affordable to healthcare systems. Liver cancer is one of the few cancers t...
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Publication date: Available online 29 May 2020Source: Chinese Journal of Chemical EngineeringAuthor(s): Weijie Ding, Min Chen, Ming Zhou, Zhaoxiang Zhong, Zhaoliang Cui, Weihong Xing
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