Helena Biosciences to develop automated blood test for chronic liver disease based on VIB and Ghent University research

16 May 2017
Helena Biosciences announced today that it is commercialising a new blood test for Chronic Liver Disease (CLD) in cooperation with the Ghent University branch of VIB – the life sciences research institute of Flanders, Belgium. The Glyco Liver Profile will provide healthcare professionals with a comprehensive tool to diagnose and monitor patients with hepatic inflammation, fibrosis and cirrhosis, and identify cirrhosis patients at low and high risk of developing HCC within the years following the test.

Chronic Liver Disease: a heavy burden for our society
Up to 29 million people in the EU suffer from chronic liver disease (CLD). It is no understatement to say that CLD is a silent killer: liver cirrhosis might be less (in)famous than — for example — breast cancer but it is responsible for an estimated 170,000 deaths annually in Europe alone (vs. 100,000 breast cancer deaths). Hepatocellular Carcinoma (HCC), one of the most serious outcomes of cirrhosis, is the fifth most common cancer in Europe. HCC is responsible for around 47,000 deaths per year. Historically, the leading causes of cirrhosis and HCC have been viral hepatitis and alcohol consumption. Fortunately, new drugs against hepatitis C are now available, but of major concern today, the obesity epidemic leads to increasing prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) as a leading cause of cirrhosis.

Glyco Liver Profile test has a clear advantage for patients
Glyco Liver Profile or GLP is a novel diagnostic test for chronic liver disease. It has the ability to diagnose and monitor CLD from liver inflammation to early and late stage fibrosis and early cirrhosis diagnosis. With its broad scope, this non-invasive test offers outstanding advantages over other tests on the market. Furthermore, GLP provides a powerful ability to predict a patient’s likelihood of developing HCC within the next 5 years. This is a huge additional benefit which no other non-invasive test can provide.

Glyco Liver Profile from Helena Biosciences will allow doctors to stratify patients into low and high-risk groups. Professor Hans Van Vlierberghe, hepatologist at UZ Gent explains: ‘The use of the test in patients with cirrhosis of the liver allows to create a customized follow-up schedule for each patient. On the basis of the risk measured, they could receive intensive or less intensive screening. This will lessen the cost and burden for patients at low risk and might improve early diagnosis for patients at high risk.’

GLP, a test built on molecular insights
Glyco Liver Profile was first conceived in 2004 by Nico Callewaert and Roland Contreras (VIB-UGent). They collaborated with Hans Van Vlierberghe and Joris Delanghe at UZ Gent for the clinical translation of the technology. The first results led to a publication of this ground-breaking research in Nature Medicine (Noninvasive diagnosis of liver cirrhosis using DNA sequencer-based total serum protein glycomics, Callewaert et al., 2004). The test analyses the glycome of serum proteins, which are mainly produced by the liver. Over the last 13 years, the Callewaert lab developed and refined the test to offer a diagnostic test that can now easily be adopted into clinical laboratories on a routine clinical platform: Helena’s V8 Nexus Capillary Electrophoresis analyser. Ready for clinical introduction, Glyco Liver Profile is a mature in vitro diagnostic (IVD) with personalised medicine benefits. It offers an alternative to the currently available costly, invasive and often inaccurate options.

Professor Nico Callewaert (VIB-UGent): ‘It is really fulfilling to see that our 15-year long research and development work is now leading to a better clinical laboratory test that will improve liver disease management, hopefully for millions of patients. Bringing Glyco Liver Profile to hepatology clinics is made possible through our collaboration with Helena, as their instruments are already in hundreds of clinical labs all over the world. We thank all of our co-workers and funders over this long track of translational research, especially also the Fournier-Majoie Foundation, as well as all of the patients who volunteered to participate in the clinical studies. We will keep working relentlessly with clinicians to further determine the optimal way in which this test can be used to save patient’s health and lives.’

Helena Biosciences’ Marketing and Sales Director, Doctor Adam Stephenson commented: ‘We are very excited about this new product and look forward to driving its success throughout the global market. Chronic liver disease is an underestimated silent killer causing many hundreds of thousands of deaths each year, where the costs and pressures on healthcare systems are enormous and continue to increase, especially with the proliferation of NAFLD and NASH.’ Helena Biosciences have been translating this scientifically driven technology to work on their fleet of automated capillary electrophoresis systems, which are used routinely in laboratories all over the world for serum protein and haemoglobin analysis. As Doctor Stephenson commented, ‘This obviously gives us a huge advantage and opportunity to deliver a revolutionary blood test to hospitals so that they can streamline patient stratification and treatment strategies like nothing ever seen before. This will be a reference test at the front-line of laboratory medicine for every major testing centre for many years to come’.

The Future
Helena Biosciences, with its class of fully-automated capillary electrophoresis analysers, and with multiple installations around the world, will fast-track this essential clinical test to the global market providing unparalleled diagnostic information to clinicians, whilst enhancing the utility of Helena Biosciences’ already well established V8 Nexus analyser.

Bernard Majoie, president of the Foundation Fournier-Majoie: “We are very proud to have collaborated in the development of Glyco Liver Profile. It is very satisfying to see a project of one of our laureates turn into a product that will benefit both patients and the medical world.”
Since 2009 prof Nico Callewaert received support from the Foundation Fournier-Majoie to continue his research. The VIB-UGent team and the foundation collaborated closely during the process until the commercialization of the discovery.

Nico Callewaert  (VIB-UGent)