Enhanced Early Detection of Liver Cancer

EpiMedTech Global, a biotech company developing early disease detection tests, announced today the validation of its new test for early liver cancer detection in the peer-reviewed journal Communications Medicine, part of the Nature Portfolio.

Early diagnosis is crucial for preventing deaths from liver cancer, one of the most aggressive cancers, which is often asymptomatic in its early stages. Each year, over 800,000 new cases are diagnosed globally, and more than 700,000 people die from this disease. Current screening methods like ultrasound, CT, and MRI have low sensitivity for early-stage hepatocellular carcinoma (HCC), and biopsies involve risks and discomfort. Therefore, there is an urgent need for non-invasive, more accurate early diagnostic methods.

Traditionally, Alpha-fetoprotein (AFP) has been used as a biomarker for HCC, but it shows insufficient sensitivity for early detection, with a rate below 60%. Recent research on circulating tumor DNA (ctDNA) has shown promise but also significant limitations, including low mutation frequency and difficulty in detection at early stages.

Peripheral white blood cells (PBMCs) circulate in our blood and are easily accessible. Our previous studies showed that DNA methylation in PBMCs could indicate the presence of liver cancer, even at early stages, leading to further research. We developed a test using bisulfite conversion and next-generation sequencing to assess four gene methylation states (M4). In collaboration with the World Class Clinical Research Institute in Dhaka, Bangladesh, icddr,b, we tested 403 individuals, improving early detection of liver cancer when combined with AFP.

The M4+AFP method increases detection sensitivity to 88.5% in the early stages and 95.7% in late stages, while almost completely eliminating false positives and negatives, making it a highly reliable tool. Unlike ctDNA, the amount of DNA from PBMCs does not depend on cancer stage or proximity to blood vessels, offering universal applicability.

CEO Szyf of EMTG expressed his optimism, stating: Our efforts mark a notable progression in liver cancer diagnostics through DNA methylation in PBMCs. The company plans to provide this test using its automated, CLIA/CAP accredited epigenetic testing platform.

Reference:

Cheishvili, D., Wong, C., Karim, M.M. et al. Clinical validation of peripheral blood mononuclear cell DNA methylation markers for accurate early detection of hepatocellular carcinoma in Asian patients. Commun Med 4, 220 (2024). https://doi.org/10.1038/s43856-024-00652-2

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