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

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

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.
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.
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.