VolitionRX entered a collaboration with Abcodia to validate its Nucleosomics™ technology for cancer diagnosis, including its suite of NuQ™ tests. VolitionRX will gain access to Abcodia's biobank of over five million human serum samples.
"We believe that the data from the successful validation of thousands of well-annotated samples would be sufficient for us to pursue our goal of applying for CE Mark regulatory approval in Europe in 2012, and would form a considerable basis for our applications for FDA approval thereafter,” says Cameron Reynolds, CEO of VolitionRX.
Abcodia was spun out from University College London (UCL). Its biobank includes samples taken each year for up to seven years by scientists at UCL from more than 200,000 initially healthy volunteers, many of whom went on to develop a range of cancers and other conditions.
Under the agreement, VolitionRX will initially receive samples from a combination of pancreatic, colorectal, and lung cancers as well as control samples for noncancer conditions such as Crohn disease, arthritis, and serious trauma. Following successful validation of VolitionRX’ Nucleosomics assay on those samples, Abcodia will provide further samples of cancer and noncancer controls.
“Abcodia's samples are fully annotated, and the seven-year period over which they were taken will allow us to undertake longitudinal validation of our technology,” remarks Jake Micallef, CSO of VolitionRX. “The significant number of controls we will receive from Abcodia will also help us to ensure the specificity of our tests.
“While we're initially testing three key cancers—pancreatic, colorectal, and lung—we hope to validate the NuQ test on many other cancers upon future agreement with Abcodia." Under terms of the current agreement, the firms may negotiate supply of samples for additional cancers subject to the same terms as this initial agreement.
VolitionRX’ development activities are currently centered in Belgium and will be augmented by commercialization work in Singapore with a focus on bringing its diagnostic products to market first in Europe, then the U.S. and worldwide.
VolitionRX is using the Nucleosomics platform to develop blood-based epigenetic cancer screening tests. The pipeline includes NuQ, a test for the detection of the level of all nucleosomes in a patient’s blood; NuQ-X, a family of tests for the detection of nucleosomes containing specific nucleotides (currently VolitionRX has three NuQ-X tests); and NuQ-V and NuQ-M, a family of tests for the detection of nucleosomes containing specific histone variants that identify the type of cancer present (VolitionRX currently has four NuQV tests and two NuQ-M tests).