FDA grants breakthrough device designation to Elecsys GALAD score to support liver cancer diagnosis
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The FDA granted breakthrough device designation to the Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma.
The algorithmic Elecsys GALAD score (Roche) is a serum biomarker-based model that predicts the probability that patients with chronic liver disease have HCC.
The minimally invasive approach incorporates sex and age with results of three assays to provide greater insights into a person’s HCC risk.
“HCC is the fourth leading cause of cancer-related death worldwide, with the highest burden of disease in East Asia and Africa,” Amit Singal, MD, medical director of the liver tumor program and clinical chief of pathology at UT Southwestern Medical Center, said in a Roche-issued press release. “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.”
Liver cancer incidence is rising and only 44% of patients are diagnosed with early-stage disease. Five-year survival rates are approximately 70% for those diagnosed at an early stage, compared with less than 16% for those diagnosed with late-stage disease.
American Association for the Study of Liver Diseases guidelines recommend surveillance for individuals at high risk for HCC. This includes ultrasound, sometimes with a blood test to check protein levels.
However, research has shown ultrasound may miss more than half of early-stage HCCs, meaning other diagnostic methods — such as abdominal MRI or CT scan, or liver biopsy — often are required.
“We are excited about FDA’s recognition of the potential clinical benefit the Elecsys GALAD score could bring in diagnosing hepatocellular cancer at an early stage,” Thomas Schinecker, CEO of Roche Diagnostics, said in the release. “The combination of blood-based biomarkers with clinical algorithms has the potential to significantly reduce mortality of [patients with HCC] as they can receive a more timely diagnosis and treatment.”