Laboratory Automation System Installed to Increase Throughput Capacity for Large Clinical Trials

Automation will first be used to accelerate the testing of blood samples in an expanded colorectal cancer screening trial.

VolitionRx Ltd. (Namur, Belgium and Singapore), a company focused on developing blood-based diagnostic tests for different types of cancer, has installed a Tecan EVO200 automated liquid handling system in its Namur laboratory. The Tecan EVO200 is a robot that will significantly accelerate VolitionRx’s large-scale clinical studies by increasing the throughput and rate of blood sample analysis by up to 5 times that of the current manual methods.

Initially the robot will be used in a stand-alone mode but Volition is in the process of establishing a Laboratory Information Management System (LIMS) which will integrate the robot into a wider automation system. This will provide a workflow incorporating blood sample recognition, testing, data capture, and quality control as part of a quality management system.

VolitionRx also recently outsourced large-scale production of their NuQ kits to complement the increased sample processing capabilities the EVO200 system brings. Outsourced kit production and implementation of the quality system will be overseen by newly appointed Chief Operations Officer, Gaetan Michel. These are key milestones in moving towards European CE market approval and the ramp-up for the release of kits into the clinical setting.

Installation of the robot is particularly significant as the company has now increased by 3,000 (from 11,000 to 14,000) the number of prospective blood samples to be included in its on-going colorectal cancer clinical trial, jointly sponsored by VolitionRx and the University of Copenhagen. The study is designed to evaluate the validity of VolitionRx’s proprietary NuQ panel as a first-step screening tool for colorectal cancer and has been expanded by 42% since the study began. The additional blood samples are being collected by Prof. Hans Jørgen Nielsen, professor of surgical oncology at Hvidovre Hospital (University of Copenhagen), and collaborators at 7 additional Danish hospital departments.

Cameron Reynolds, CEO of VolitionRx, said, “This is an exciting time for Volition with lots of positive change as we move towards regulatory approval and clinical launch of our products. The automated sample testing technology we have invested in will speed up our workflow, and the extension to our trial with Hvidovre Hospital will give us the opportunity to analyze further data in relation to colonoscopy findings. The next key milestone will be the release of the first data from our pivotal Danish trials at the Aegis Capital Corp. 2014 Healthcare & Technology conference, to be held September 10–13, 2014, in Las Vegas, Nevada.”

Other clinical trials assessing the effectiveness of Volition’s assays include a 4,000-patient prospective study of patients with the 20 most prevalent cancers at University Hospital in Bonn (Germany) and a 250-patient study into colorectal cancer at CHU-UCL Mont Godinne Hospital in Belgium.

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