Updated on 15 March 2013
The lab facilities and office at Namur, Belgium, became operational in March 2011. In September of the same year, the company filed for three patents for NuQ, NuQ-X and NuQ-V families of tests. In July 2012, the company signed an agreement with Stefan Holdenrieder of Rheinische Friedrich-Wilhelms-Universität at Bonn, Germany, for three clinical trials.
The research kits were launched in December 2012. VolitionRx, which expects to set up an office in the US in 2013, is initially targeting researchers for the sale of its kits. Presently, it is manufacturing the kits in Belgium, but plans to outsource production when the demand rises. The company has commenced a large internal clinical study for its Nucleosomics diagnostic products at its own laboratory. "We plan to commence a number of larger trials in the first half of the year for several new cancers," says Mr Reynolds, adding that the company is in discussions with big diagnostic companies regarding possible licensing of their products.
VolitionRx has developed a range of immunoassays based on the company's proprietary technology Nucleosomics, an epigenetic profiling platform for the detection of histone variants and post-translational modifications as well as DNA modifications in intact nucleosomes. The technology was acquired through the acquisition of ValiBio SA by VolitionRx for $1 million. HyperGenomics, which uses existing biopsy techniques to identify specific cancers through analysis of hypersensitive sites in cells, was the other technology acquired through this deal.
Nucleosomics allows profiling of nucleosomes through a liquid biopsy (of serum, plasma or other biofluids) in a standard ELISA format. The tests are a simple double-antibody ELISA that captures and labels nucleosomes in a sample. The company is primarily focused on using blood samples as it allows disease detection without an invasive surgery.
The Nucleosomics technology involves identification and measurement of a number of nucleosomes structures with almost innumerable potential combinations, and is therefore an entire platform. "As far as we're aware, we are the only company working on nucleosomes in blood, and our broad patents and applications reflect that," says Mr Reynolds. The company has developed a range of 15 immunoassays for the detection and analysis of nucleosome structures that was launched in December 2012. The price ranges from $1,060 to $1,330 (EUR799-EUR 999) for a 96-well plate kit. "Concurrently, the major market for our tests is their clinical use in oncology and other conditions such as endometriosis," explains Mr Reynolds.