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Levels Dx detects liver cancer early—when it’s still curable 

Levels Diagnostics (Levels Dx) is a Dutch biotech company developing a next-generation blood test for the early detection of hepatocellular carcinoma (HCC), the most common and deadly form of liver cancer. HCC predominantly arises in patients with liver cirrhosis and is responsible for over 800,000 deaths annually worldwide. Although curative treatments are possible when HCC is detected early, current surveillance methods—primarily ultrasound—lack sufficient sensitivity, resulting in most patients being diagnosed at advanced stages with poor survival outcomes. 

Levels Dx addresses this critical unmet need with a novel in vitro diagnostic (IVD) test based on six proprietary blood biomarkers that enable highly accurate detection of early-stage HCC. Using advanced proteomics and machine-learning-based algorithms, the company has demonstrated unprecedented diagnostic performance, achieving 95% sensitivity and 92% specificity in early-stage disease—far surpassing current clinical standards and competing solutions. The biomarkers are protected by a strong patent portfolio extending to 2043. 

The test is designed to integrate seamlessly into routine clinical workflows: a simple blood draw followed by a rapid, multiplex laboratory assay with results available within 30–60 minutes. By enabling earlier diagnosis, Levels Dx aims to significantly improve patient survival and quality of life while reducing healthcare costs associated with late-stage cancer treatment. 

Founded in 2017 and based at the Leiden Bio Science Park, Levels Dx is led by an experienced multidisciplinary team with deep expertise in oncology, diagnostics, and commercialization. The company collaborates closely with leading academic hospitals across Europe and is engaged with major diagnostics companies as potential strategic partners. 

Targeting a rapidly growing global liver cancer diagnostics market, Levels Dx plans to launch its test in the EU and USA by 2031. Through early detection, strong clinical validation, and strategic partnerships, Levels Dx’s mission is to transform liver cancer outcomes by ensuring patients are diagnosed when treatment can still make a life-saving difference. 

BioBusiness Masterclass
Year of participation
2026

 

Contact
Coen Breedveld (founder)coen@levels.bio