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Roche: FDA breakthrough status for cancer diagnosis tool

(CercleFinance.com) - Roche said on Wednesday that the US Food and Drug Administration has granted breakthrough therapy designation for a product intended to help the diagnosis of liver cancer.


The Swiss drugmaker said that the FDA has granted breakthrough device designation to the Elecsys Galad score to aid diagnosis of early stage hepatocellular carcinoma, a particularly deadly form of cancer.

The Galad score is a serum biomarker-based model that predicts the probability of having hepatocellular carcinoma in patients with chronic liver disease.

Hepatocellular carcinoma is the fourth leading cause of cancer-related death worldwide, with high mortality - particularly in East Asia and Africa.

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