VolitionRx Limited announced that University Hospital Bonn in Germany is initiating a confirmatory study to evaluate the Nucleosomics^® platform, VolitionRx’s novel technological platform for the diagnosis of lung cancer that utilizes an individualized blood test. VolitionRx is a life science company committed to developing effective, efficient tests for cancer diagnosis. 

This confirmatory study, to be developed as a separate trial, will merge with a larger study (4,000-subject trial) evaluating VolitionRx’s NuQ^® tests in 20 or more prevalent cancers. Researchers are collecting samples from patients suffering from several conditions, including patients with cancer as well as healthy individuals who will function as the control point of the study. Assessments will be made in 2015, and will include some samples from the 4,000-subject trial as well.

Dr. Stefan Holdenrieder at University Hospital Bonn is serving as the lead investigator for both trials. Both Dr. Holdenrieder and his research team will lead a confirmatory evaluation that will assess 600 blood samples: 400 from patients with lung cancer at different stages, 100 from patients with benign lung diseases crucial for differential diagnosis, and 100 from healthy individuals.

Dr. Stefan Holdenrieder said in a press release: “Following the encouraging results reported from VolitionRx’s pilot lung cancer study in both blood and sputum at the BioWin Day 2014 in Belgium last month, I am looking forward to conducting a subsequent study in blood to further validate the accuracy of the Nucleosomics^® technology in lung cancer. Early detection of lung cancer remains a high unmet medical need across the globe and the use of promising biomarkers such as modifications of nucleosomes — which play an important role in the development and progression of lung cancer — may offer the potential to enhance the accuracy of early cancer detection.”

Dr Jake Micallef, Chief Scientific Officer, added: “The confirmatory study led by Dr. Holdenrieder at University Hospital Bonn serves as further validation of the data we have shown to date demonstrating the accuracy and sensitivity of our NuQ^® test not only lung cancer, but also in other prevalent cancers including colorectal and prostate. We look forward to initiating the confirmatory study and hope that the results will confirm the accuracy of the test in detecting lung cancer, this time in a larger number of subjects.”

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A previous pilot test evaluated if the NuQ^® platform could detect lung cancer in blood and in sputum samples, which included the use of 46 samples from non-small cell lung cancer (NSCLC), chronic obstructive pulmonary disease (COPD) and healthy individuals. The technology detected advanced and early stage lung cancer in sputum and blood samples.

The  NuQ^® tests, through the Nucleosomics^® platform, identify the presence of epigenetic cancer signals in the blood and sputum. The results show that the NuQ^® test detected 85 percent of lung cancer cases through sputum, no false positives were reported for healthy individuals, and lung cancer was differentiated from COPD. About 76 percent of patients with lung cancer were detected through blood samples, while recording one false positive.