VolitionRx study confirms stability of circulating cell-free nucleosomes as biomarkers for cancer diagnostic blood tests
June 14, 2016 – NAMUR. VolitionRx Limited announced full results from a prospective assessment of pre-analytical variables contributing to the accuracy of its NuQ® blood test that confirm the stability of circulating cell-free nucleosomes (cfnucleosomes) as biomarkers in cancer. The findings were published on 13thJune 2016 in the article, “Pre-analytical variables of circulating cell-free nucleosomes containing 5-methylcytosine DNA or histone modification H3K9me3” in the Scandinavian Journal of Clinical and Laboratory Investigation, an international scientific journal focused on clinically-orientated biochemical and physiological research.
VolitionRx’s proprietary NuQ® blood tests are based on biomarker assays that can identify fragments of chromosomes, called nucleosomes, circulating in the blood and analyze them for epigenetic modifications that signal that cancer is present.
The study, led by VolitionRx lead scientist Dr. Marielle Herzog working with the Department of Surgical Gastroenterology, Hvidovre Hospital, University of Copenhagen, Denmark and the Institute of Clinical Medicine, University of Copenhagen, Denmark evaluated sampling and handling factors of the blood draw and storage process of the NuQ® tests that can impact the tests’ stability and fragility. For accurate results in any blood test, it is important to confirm that the results of the test are the same regardless of when and how the blood sample is taken.
VolitionRx Chief Scientific Officer Dr. Jake Micallef commented, “The findings of this study are very good news for us, especially as we head to market in the EU, as no nucleosome stability or fragility issues were found and no special blood draw requirements were needed. What this means for patients is that our NuQ® test will be relatively easy to complete, with no need to fast or limit testing to a specific time of day. The test will also be easy, convenient and cost-effective for both the doctor and the lab since it can be done during a regular blood draw with no special collection, separation, handling or storage requirements.”
The study investigated the influence of the following six elements which could affect cfnucleosome blood test stability and/or fragility:
The study concluded that the levels of circulating cfnucleosomes appear stable in most pre-analytical settings, including the processes of sampling and handling blood samples at room temperature prior to centrifugation.
VolitionRx Chief Executive Officer Cameron Reynolds, added, “The validation of our stability study with the publication of this article represents yet another important step toward providing an accurate and easy to use NuQ® diagnostic blood tests to physicians and their patients for the early detection of cancer. This result is key to making our tests low cost and easy to use, as eating, time of day and time of month of sample collection had no meaningful difference in the results for an individual person’s biomarker result.”
SOURCE VolitionRx Ltd