Roche’s Elecsys GALAD Score that Predicts HCC Occurrence, Bags Breakthrough Designation

By Ruchi Jhonsa, Ph.D.

Diagnosing a disease early on can be a challenge especially when the tools for detection are insensitive. This challenge is regularly faced in diagnosing liver cancer early on. Generally, an ultrasound examination is ordered when a patient presents with liver cancer-like symptoms. However, it is less conclusive and the interpretation can get complicated if the patient is obese or has fatty liver disease. A recent meta-analysis data suggest that ultrasound may miss more than half of early-stage liver cancers. If ultrasound fails to give a clear picture, doctors will suggest patients to get either their serum alpha-fetoprotein (AFP) levels checked, which may or may not conclusively diagnose cancer or get an abdominal scan, abdominal MRI scan or liver biopsy, all of which help in detection with high accuracy but with little comfort.

Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) accounts for 90% of cases of liver cancer and is the fourth leading cause of cancer-related deaths worldwide. This cancer is most prevalent in Asian countries where the most common risk factor of the disease, Hepatitis B is found in abundance. Despite significant advances in the treatment, the high mortality in liver cancer patients is mainly seen due to late cancer detection. According to the data from NCI’s SEER program, only 44% of the liver cancer patients were diagnosed at an early stage. Of them, 70% of the patients were still alive after 5 years. On the contrary, less than 16% survived a period of 5 years if they were diagnosed at a late stage.

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.”

To improve the cancer diagnosis, the Swiss drugmaker Roche announced that the FDA has granted breakthrough designation to its Elecsys GALAD score, which is a serum biomarker-based model designed to predict the probability of having hepatocellular carcinoma in individual patients with chronic liver disease. The GALAD score is derived from the weighted average of five factors namely gender, age and serum levels of biomarkers AFP-3, Elecsys AFP and PIVKA-11. So far, this is the first score to get approval from the FDA and is proposed to improve the efficiency of liver disease diagnosis at an early stage when combined with ultrasound examination.

The GALAD Score

Pioneered by Prof. Johnson, Deputy Director of NWCR Centre and Professor in Translational Oncology at the University of Liverpool, and his colleagues from the UK, the GALAD score takes into consideration five factors, which have shown a considerable correlation with the occurrence of liver disease. Elevation of Alpha1-fetoprotein or AFP is a sign that the liver is damaged due to hepatitis, cirrhosis or tumorigenic growth. However, the elevation of AFP-L3, an isoform of AFP and PIVKA-II, an abnormal form of prothrombin is a sign that the liver cells are destined to become cancerous. Combining each of these factors with gender and age in an algorithm result in a score that can determine the probability of any liver disease to be cancerous.

Thomas Schinecker, CEO of Roche Diagnostics expressed his excitement at the news and said, “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. The combination of blood-based biomarkers with clinical algorithms has the potential to significantly reduce the mortality of HCC patients as they can receive a more timely diagnosis and treatment.”

References

1. https://www.roche.com/media/releases/med-cor-2020-03-04.htm
2. D et al., 2001, Clin Chim Acta, 313(1-2):15-9
3. Johnson et al., 2014, Cancer Epidemiology and Prevention Biomarkers, 23(1):144-153

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Author

Ruchi Jhonsa