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HepaCheC - an in vitro diagnostic assay for the early detection of liver cancer

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A simple blood test for early diagnosis of primary liver cancer

The EU-funded http://glycobond.com/technology/hepachec (HepaCheC) project has developed a business plan for the clinical validation and commercialisation of a biomarker-based blood test for early diagnosis of hepatocellular carcinoma (HCC).

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HCC is one of the leading causes of death from cancer worldwide. Current European and United States’ guidelines recommend ultrasound for diagnosis. The accuracy of this method is user-dependent and only able to identify relatively shallow tumours of a certain size. An unmet need growing globally Early diagnosis is critical for successful treatment and currently, only 10 % of HCC patients are diagnosed at an early enough stage. Alternative methods are therefore much needed. Changes in lifestyle in the West are also fuelling incidence rates. “A combination of an increase in hepatitis B and C infections and the obesity epidemic predisposes individuals to develop HCC,” explains Dr Anki Nilsson, project leader and chief operating officer of Glycobond AB, project coordinator. Simple yet effective test for HCC Glycobond AB, a private independent company established in 2011 by researchers at Linköping University, Sweden, developed a blood test that is simple yet highly selective and specific. Based on the standard enzyme-linked immunosorbent assay, or ELISA, it can be incorporated into any standard diagnostic or research set-up, requiring only elementary lab know-how for operation. The diagnostic test, HepaCheC®, detects a specific liver cancer biomarker: fucosylated alpha1-acid glycoprotein (AGP). Glycobond’s patented mono-F peptide constitutes the solid phase of the HepaCheC® assay, followed by an in-house-developed polyclonal AGP-specific antibody. Clinical validation and commercialisation With part-funding via the EU project HepaCheC, the team worked towards the commercial launch of the HepaCheC® assay. “Our customers are clinical laboratories but the decision to use HepaCheC® for aid in diagnosis of primary liver cancer will come from clinicians and key opinion leaders (KOLs) within the field, and the project aimed to raise awareness amongst these key players,” says Dr Nilsson. The main outcomes of the project include the successful identification of key issues in HCC diagnosis and engagement of KOL partners in clinical studies for validation of HepaCheC®’s clinical utility in Europe, China, Japan and the United States. “We also have a much-improved understanding of the market and positioning of HepaCheC® as an adjuvant diagnostic method,” adds Dr Nilsson. This could drastically improve treatment outcomes at a very small cost with great benefits for patients and a concomitant reduction of healthcare costs. Challenges with unexpected beneficial outcomes “As HCC has a low abundancy in Europe as compared to Asia, we were aware of the problems of finding enough and relevant patient samples for performing clinical studies on HepaCheC®,” emphasises Dr Nilsson. However, the researchers were positively surprised at the willingness of KOLs to participate in clinical studies on HepaCheC®. Clinical studies are costly. Consequently, the team has applied for EU support in a phase II application submitted recently. Future use of HepaCheC® in national schemes The next step is to perform the clinical studies and work for inclusion of HepaCheC® into surveillance guidelines and national reimbursement systems. Dr Nilsson sums up: “We are planning inclusion of HepaCheC® into analytical platforms and have already initiated collaborations with diagnostic companies within the field. Our first market goal is Europe with United States and Japan following closely after.”

Keywords

HepaCheC, HCC, diagnostic, blood test, liver cancer, Glycobond, biomarker, hepatocellular carcinoma

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