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

The Elecsys GALAD score aims to support clinicians in diagnosing hepatocellular carcinoma by giving them more timely and accurate information to make earlier interventionsWhen hepatocellular carcinoma is detected and managed at the very earliest, patient’s 5-year survival rates can increase to over 70%¹Utilizing blood-based biomarkers, as part of the Elecsys GALAD score, is minimally invasive to patientsBasel, 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).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 that are on the rise.² While recent developments in screening and new treatments are making advances in the prevention, diagnosis and treatment of HCC, clinicians still face challenges in diagnosing the disease early enough. Only 44% of liver cancer patients are diagnosed at an early stage.³ Of HCC patients, which are diagnosed with late-stage disease, less than 16% survive a period of 5 years. Of the patients diagnosed at an early stage, 70% percent are still alive after five years¹. Therefore, diagnosing HCC, as early as possible, is essential to improving patient outcomes.About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.Roche Group Media Relations
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– Nicolas Dunant (Head)
– Patrick Barth
– Daniel Grotzky
– Karsten Kleine
– Nathalie Meetz
– Barbara von Schnurbein AttachmentRoche_MediaRelease_04032020_EN