Noninvasive Blood Test Detects Pancreatic Cancer Biomarkers

For the prognosis of patients with pancreatic cancer, new biomarkers are required for earlier, pre-symptomatic diagnosis and as epigenetic mutations take place at the earliest stages of tumorigenesis and they offer new approaches for detecting and diagnosing disease.

Nucleosomes are the repeating subunits of DNA and histone proteins that constitute human chromatin and because of their release into the circulation, intact nucleosome levels in serum or plasma can serve as diagnostic disease biomarkers, and elevated levels have been reported in various cancers.

Clinical scientists at Lund University and Skane University Hospital (Lund, Sweden) carried out a prospective study consisting of 59 individuals that comprised serum samples from 25 patients with pancreatic cancer, 10 with benign pancreatic disease, and 24 healthy controls. As detection of late-stage pancreatic cancer is of little clinical value, all subjects included in this study were selected from operable, early-stage disease. All patients underwent pancreatic resection with curative intent, with 23 patients undergoing pancreaticoduodenectomy and two patients undergoing distal pancreatectomy.

Epigenetic profiles of circulating cell-free nucleosomes (cf) nucleosomes of subjects with pancreatic cancer, subjects with other pancreatic conditions, and healthy control subjects were investigated using an enzyme-linked immunosorbent assay (ELISA)-based NuQ assay (VolitionRx Limited; Namur, Belgium). Nine epigenetic features of serum cell-free nucleosomes were measured. Diagnostic sensitivity for individual nucleosome-based biomarkers at 90% specificity, ranged from 0% to 40% for cancer versus healthy and benign and from 0% to 60% for cancer versus healthy.

Analysis of the blood samples demonstrated that a panel of five NuQ assays distinguished 84% (21 of 25) of the early-stage pancreatic cancer cases from healthy subjects, with only two false positive results among the healthy subjects. The detection rate of the test was improved further to 92% (23 of 25) of cancer cases by inclusion of the classical CA19-9 cancer biomarker with no false positives results among the healthy subjects.

Roland Andersson, MD, PhD, Professor of Surgery, and senior author of the study said, “Pancreatic cancer has a poor prognosis, with a five-year survival rate of only 6% to 7%, mainly due to the asymptomatic nature of its early stages, aggressive biological behavior, and limitations of current detection technologies. Our pilot study shows that VolitionRx's NuQ blood-based diagnostic tool accurately detects and distinguishes patients with pancreatic cancer from those with benign cases and from healthy patients. On a practical level, these are tests that use a single, small volume of blood and have potential as a valuable screening option, as the test is able to detect with high sensitivity even early stages of disease.” The study was published on October 7, 2015, in the journal Clinical Epigenetics.

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