HCCBloodTest – A blood test for cirrhotic patients at high-risk for the development of hepatocellular carcinoma (HCC).

As the second-leading cause of global cancer death, hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver, affecting more than 800,000 people annually. Major risk factors for HCC include cirrhosis, infection with hepatitis B (HBV) or C virus (HCV), alcoholic liver disease, and non-alcoholic fatty liver disease. Worldwide, approximately 80-90% of patients with HCC occur in the setting of underlying cirrhosis. Coupled with a 2-4% annual incidence for HCC, cirrhotic patients are classified as a high-risk group for surveillance efforts aimed at early detection when potentially curative treatments can be offered. Current surveillance strategies support screening for cirrhotic patients using abdominal ultrasound every 6 months, irrespective of etiology. While alpha-fetoprotein (AFP) has also been widely used as a diagnostic marker for HCC, it is insufficiently sensitive or specific for use alone in a screening or surveillance setting and is suboptimal for routine clinical practice. Therefore, better screening and diagnostic biomarker assays are needed to improve the early detection of HCC. Shown to have a high diagnostic accuracy for the detection of HCC in cirrhotic patients, the HCCBloodTest offers an option to improve risk prediction and patient management.

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon(R), is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R), a blood-based test for lung cancer detection, has received CE mark in Europe.

Source