VolitionRx Limited has announced that its Nucleosomics platform technology for the diagnosis of lung cancer will be evaluated in a confirmatory clinical study by the University Hospital Bonn in Germany.
The Nucleosomics platform can measure and identify nucleosome structures in the blood, the basic units of DNA packaging, consisting of a DNA segment wound in sequence around eight histone protein cores.
The confirmatory study will occur in parallel with a larger study, also carried at the University Hospital Bonn and enrolling 4,000 patients, that will assess VolitionRx’s NuQ assay in 20 of the most common cancers.
Around 600 blood samples from the larger study will be analyzed by Priv-Doz. Dr. Stefan Holdenrieder, leader of both clinical trials. Of these, 400 will be from patients with different histological forms of lung cancer and at different stages of the disease; 100 will derive from patients diagnosed with benign lung diseases; and 100 samples will be from healthy controls to compare with the different nucleosome alterations in the diseased samples.
“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. Stefan Holdenrieder said in a press release.
“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”, added Chief Scientific Officer Dr. Jake Micallef.
This diagnostic platform had already been tested for the detection of lung cancer in the blood and sputum of 46 patients who suffered with non-small cell lung cancer (NSCLC) or chronic obstructive pulmonary disease (COPD), proving successful in its sensitivity and specificity to detect this type of malignancy in both types of samples.