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Roche: FDA Grants Breakthrough Device Designation To GALAD Score - Quick Facts

Roche (RHHBY) said the U.S. FDA has granted Breakthrough Device Designation to the Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma. The GALAD score is a serum biomarker-based model that predicts the probability of having hepatocellular carcinoma in patients with chronic liver disease. Combined with ultrasound, the Elecsys GALAD score is minimally invasive to patients, and has the potential to support clinicians by giving them more accurate information at an earlier stage, Roche said.

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.

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