Diagnostics Home_Spotlight — 19 May 2015
VolitionRx a drop of blood to detect colorectal cancer

Belgian Volition – a subsidiary of Volition Rx – is a life sciences company located in Namur (Belgium) focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions. By bringing together the ELISA diagnostic technology with cutting-edge nucleosome detection and analysis techniques, the start-up aims to revolutionize cancer detection.

Colorectal cancer: the third most common in the world

According to the World Cancer Research Fund International, colorectal cancer (CRC) is the third most commonly occurring cancer in the world, with nearly 1.4 million new cases diagnosed in 2012. It is estimated that worldwide, the number of cases will rise to 2.4 million by 2035[1]. It is important to know that colorectal cancer develops slowly (over 10-15 years) and that when symptoms appear, it is often too late to run effective treatment: 35% of patients suffering from CRC die within the 5 years following diagnosis[2].

Current screening approaches get low compliance rate

Early diagnosis is thus key to treat patients effectively. Yet, a significant proportion of the global population remains reluctant to be screened for CRC: in fact, one-third of the approximately 90-million U.S. population that is eligible for CRC screening is not currently being screened. Less than 50% of the 150-million patients eligible in Europe for screening and less than 25% of the 70-million Japanese eligible population are actually tested. These 150-million-plus unscreened patients are VolitionRx’s first target market.

We anticipate that, because of their ease of use and affordability, our tests have the potential to become the method of choice for accurate cancer screening, allowing for earlier detection of cancer and inclusion of individuals who, for reasons such as time, cost or dislike, are not currently screened,” said Jake Micallef, Chief Scientific Officer of VolitionRx. “We believe our blood test for colorectal cancer would be preferable to patients compared to unpleasant faecal tests and for those who refuse an invasive colonoscopy, common reasons for low acceptance and compliance to current approaches.” [3]

Pushing CRC screening to the next level

Combining global epigenetic profiling with a simple low cost immunoassay technology, VolitionRx has developed Nucleosomics®, a proprietary platform aimed at measuring and identifying signatures of nucleosomes circulating in the blood.

Circulating cell-free, nucleosome bound DNA fragments contain mutations found in cancer tissue from the same patients suggesting a tumor chromatin origin for, at least some, circulating nucleosomes. Profiling of global levels of epigenetic modifications in nucleosomes can provide disease-specific diagnostic information[4] explains Mariel Herzog, lead scientist at Belgian Volition.

 “This is both low cost and high throughput compared to other epigenetic-based approaches such as bisulfite conversion and polymerase chain reaction, or PCR,” Micallef explained. “NuQ markers can be used alone, in combination or with additional biomarkers to generate profiles related to specific conditions.”[5]

A medical revolution made in “Wallonia”…

Belgian Volition (which is a subsidiary of VolitionRx an American company) was formed in 2010 when the company received a EUR 1.4 million grant from the region of Wallonia to establish its R&D activities in Namur.

The location is ideal from a logistical point of view and we benefit from a strong support from the Wallonia region and its international investment and trade agency (AWEX)”, says Gaëtan Michel, Chief Operating Officer at Belgian Volition.

The company is working in close collaboration with several Walloon academic and industrial players such as ImmuneHealth (global biomarker Contract Research Organization) for pilot study to assess the feasibility of VolitionRx’s technology for detecting prostate cancer; University Hospital Center CHU de Liège for clinical studies on lung cancer; University Hospital Center Mont-Godinne for clinical studies on colorectal cancer; MasTHerCell (Advanced Cell Therapy Contract Manufacturing Organization) for cells samples production and the Biopark (scientific park) for training and recruitment.

… in the spotlight of international investors

Since February 2015, VolitionRx has been listed on New York Stock Exchange market (NYSE MKT: VNRX) where the company raised USD 8.5 million through an initial public offering. Thanks to this fund raise, Belgian Volition has been able to boost its ongoing clinical studies but also to launch new ones. The company has invested in equipment, platforms and automation – multiplying by 4 their clinical samples treatment capacities.

VolitionRx screens at the NYSE Credit NYSE Josh Kuckens

The IPO confers a great visibility on the company and it opens many doors as long as you choose the right time to do it. Companies that are considering an IPO must have a disruptive innovation that is fitted with a sound proof of concept to present to investors. They also need a strong management team that will be able to handle pressure induced by heavy administrative paperwork and intense international roadshows. It took us 8 months to prepare our IPO, this is a long way to go but the return on investment is worth it. Now, we have to be very careful because the stock market is tough and investors have high expectations. Actually, IPO is just the beginning. The real challenge starts when your company is listed!”, says Gaëtan Michel.

What’s next?

VolitionRx is also expanding its R&D portfolio since the company has developed approximately 25 different assays with the Nucleosomics® platform. Following CRC, the ambition is to adapt its early stage detection test to other types of cancer such as lung, prostate, pancreatic and ovarian.

The company is aiming to secure CE mark for its first assay by the end of 2015 and is currently working with regulatory affairs specialists to introduce the tests, and meeting with organizations specializing in reimbursement in several European countries.

We hope to reach this important regulatory milestone in 2016 or 2017. We will begin in Europe, targeting Belgium, Germany, France or Denmark. Following that there will be the United States and Asia”, says Gaëtan Michel.

More info on www.volitionrx.com

Contact

VolitionRx

 

 

Gaëtan Michel
Chief Operating Officer
Belgian Volition
Phone: +32 (0) 81 72 56 49
e-mail : g.michel@volitionrx.com

 

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