Circulating Cell-Free Nucleosomes Biomarkers Confirmed for Cancer Blood Tests

Six studies were designed to assess the possible influence of pre-analytical variables. Study 1: influence of stasis and contamination with white cells and platelets. Study 2: influence of within-day variations. Study 3: influence of day-to-day variation. Study 4: influence of temperature during handling and storage, and of neoplastic disease. Study 5: influence of colonoscopy. Study 6: influence of the surgical trauma. 5mC and H3K9Me3 measurements were performed using enzyme-linked immunosorbent assays.

Blood samples for the present study were collected from healthy individuals, cancer patients, subjects undergoing colonoscopy due to symptoms of colorectal cancer, and patients scheduled for resection of primary rectal cancer, respectively. Circulating 5mC and H3K9Me3 levels were determined using an in-house NuQ enzyme-linked immunosorbent assay (ELISA) (Belgian Volition SA, Namur, Belgium). The study concluded that the levels of circulating cell free nucleosomes appear stable in most pre-analytical settings, including the processes of sampling and handling blood samples at room temperature prior to centrifugation.

Cameron Reynolds, MBA, Chief Executive Officer at VolitionRx, said, “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.” The study was published on June 13, 2016, in the Scandinavian Journal of Clinical and Laboratory.

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