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

Project Information

HepaCheC

Grant agreement ID: 807687

DOI

10.3030/807687

Project closed

EC signature date 31 January 2018

Start date 1 February 2018

End date 31 July 2018

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Biotechnology

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

GLYCOBOND AB
Sweden

Periodic Reporting for period 1 - HepaCheC (HepaCheC - an in vitro diagnostic assay for the early detection of liver cancer)

Reporting period: 2018-02-01 to 2018-07-31

Summary of the context and overall objectives of the project

HCC is one of the leading cause of cancer death worldwide. Currently, only 10% of all HCC cases are diagnosed at an early stage, which directly correlates to decreasing chances of survival: the current median survival is merely 6-20 months following diagnosis. HCC is on the rise in the Western world due to a combination of an increase in Hepatitis B and C infections and our less healthy lifestyle that has resulted in an obesity epidemic. There is therefore an eminent need to improve standardized detection protocols.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Glycobond has performed a feasibility study with the purpose of developing a business plan for the clinical validation and commercialization of HepaCheC.
The feasibility study was performed through:
- Discussions with key opinion leaders (KOLs)/clinicians within the hepatocellular carcinoma (HCC) field re-garding clinical praxis, surveillance, diagnosis and follow-up.
- Review of HCC guidelines in different countries (where available and relevant for us).
- Review of published articles (peer-reviewed journals) of relevance for HCC aetiology, spread, surveillance and diagnosis. PubMed and Google were the main search engines used.
- Discussions with large diagnostic companies with an interest in HCC surveillance/diagnosis to find out their degree of interest for incorporating a new diagnostic tool for HCC diagnosis into their analysis platforms.
- Contact with distributors of diagnostic kits and related equipment.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Current diagnostic methods (mainly ultrasound) are inadequate due to not being specific enough, being user-dependant, costly and only able to discover relatively shallow tumours that have grown to a certain size.
The HepaCheC assay, on the other hand, is a minimally invasive method (requiring a blood sample) with high selectivity and specificity that detects a specific liver cancer biomarker; fucosylated AGP (α1-acid glycoprotein). Glycobond’s patented Mono-F peptide constitutes the solid phase of the HepaCheC assay, followed by an in-house developed polyclonal AGP-specific antibody. The assay is based on the ELISA methodology, making it easily incorporated into the workflow of any standard diagnostic/research laboratory requiring only elementary laboratory know-how to be performed. The goal of Glycobond is to make HepaCheC part of the existing surveillance guidelines that are in place to monitor high-risk patients in the EU, US and Japan. If successful, the company will increase its international competitiveness and experience accelerated growth.

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