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

Informazioni relative al progetto

HepaCheC

ID dell’accordo di sovvenzione: 807687

DOI

10.3030/807687

Progetto chiuso

Data della firma CE 31 Gennaio 2018

Data di avvio 1 Febbraio 2018

Data di completamento 31 Luglio 2018

Finanziato da

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

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

GLYCOBOND AB
Sweden

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

Periodo di rendicontazione: 2018-02-01 al 2018-07-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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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