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It’s in the blood: A Namur-based company is set to revolutionise the way cancers are diagnosed

14:34 06/02/2016
The new technology has the ability to detect all sorts of other hard-to-diagnose cancers and conditions

Colorectal cancers are the third most common in the world. Of the 20 countries with the highest incidence, 13 are in Europe, and Belgium is one of them. If caught at an early stage, the five-year survival rate for these cancers is high, in the region of 90 percent. However, they are typically detected as late-stage cancers after the onset of symptoms, when the survival rate has dropped to as low as 7 percent in some countries.

Endoscopic procedures such as colonoscopy provide a high rate of early detection, but these are invasive and expensive, and in many countries are not offered in the first instance. The preferred techniques in countries with screening programmes involve stool tests, but depending where you go in in Europe, only 20 to 52 percent of adults targeted have been willing to take them.

The Namur-based operations facility of epigenetics company VolitionRx Limited is well positioned to make a big impact on improving the early detection of colorectal cancers as early as 2016, with its development of diagnostic blood tests. A panel of blood tests developed by the company is being tested in a large-scale independent clinical trial of 4,800 subjects in Denmark, who have already undergone a colonoscopy. Preliminary results released in September 2015 show that the blood tests have detected 81 percent of colorectal cancers at a specificity of 78 percent, equally well for both early- and late-stage cancers. In addition, the tests detected 63 percent of potentially pre-cancerous adenomas (or polyps) including, most importantly, 67 percent of high-risk adenomas, the most likely to become cancerous.

The tests distinguish healthy patients from those with cancers, and the type of cancer that the patient has, by capturing and measuring cancer signals. The DNA in every human cell is wound around a complex of proteins in a structure resembling beads on a string. Each individual bead is called a nucleosome. When a cell dies, the body breaks the DNA string up into individual nucleosomes which are then released into the blood to be naturally recycled. Cancers are characterised by an uncontrolled and rapid cell turnover. As the body can’t recycle such large amounts of cell debris, the nucleosome level rises in a cancer patient’s blood, making it a good marker for cancer detection. Each test, or assay, captures an intact nucleosome and identifies a specific feature that acts as a biomarker for a particular cancer or disease. Combining individual assays into a multiple panel of tests increases the accuracy. Only a single drop of blood is needed for the tests.

In essence, the technology has the ability to detect all sorts of other hard-to-diagnose cancers and conditions. VolitionRx has been granted European, US and worldwide patents to protect its proprietary technology, known as Nucleosomics, and tests, trademarked as NuQ assays.

 

The work on colorectal cancers is close to commercialisation, and one of the assays has already been CE marked, certifying that it complies with EU legislation on diagnostic device requirements. “We are in the process of finding the best combination of assays to define a panel that will diagnose colorectal cancer,” explains Belgian Volition CEO Gaetan Michel. “The final panel will consist of between four and six assays. The strategy is to get a CE mark for all the individual assays and for the final panel test in 2016. We envisage it will be ready to launch in Europe after the second quarter of 2016.”

The company was set up in Namur in 2010 with the help of a Walloon government assistance grant worth €1.05 million. “We started with two people, one lab bench and one office at the University of Namur,” says Michel, a Namur graduate with a doctorate in biochemistry. “Thanks to the Walloon government grant, we were able to set up our technology and validate it,” he says.

To accelerate work on the detection of other cancers, the parent company VolitionRx (NYSE MKT: VNRX), was listed on the New York stock exchange in 2015. It currently has a market value of about $70 million.

The move has fuelled another large 4,200-subject study at the University of Bonn in Germany, to evaluate assays for the early detection of the 27 most prevalent cancers and the differences in nucleosome structures between cancers. Other ongoing studies include a 14,000 patient prospective screening study for colorectal cancer in Denmark and smaller separate clinical studies in Belgium, Germany, the UK, the US and Singapore on diagnostic tests for lung, ovarian, pancreatic and prostate cancers and endometriosis.

The company is planning further investment. “We need to hire more people, and structure the organisation to take on the new developments,” says Michel. “We are talking to the Wallonia government and it is going to help us meet some of these challenges.” He is excited by the prospects. “The tests will be much easier and much friendlier than those currently available, especially for colorectal cancer, where people are so averse to taking the test. The aim is especially to target the large numbers of these non-compliant people to get the test done as soon as possible, because with cancer, the earlier you detect it, the more effectively you can remove it.”

This article was first published in the Wab magazine, winter 2015/2016

Written by Saffina Rana