VolitionRx Limited announced that it is initiating a study with DKFZ, the German Cancer Research Center, to evaluate VolitionRx's NuQ blood tests for the detection of pancreatic cancer.

This collaboration follows VolitionRx's announcements last year of highly encouraging data from two preliminary studies for pancreatic cancer detection. Results from a 59-patient trial with Lund University in Sweden, published in the journal Clinical Epigenetics, demonstrated a detection rate of 92 per cent (23 of 25) of pancreatic cancer cases at 100 per cent specificity using a panel of four NuQ biomarker assays and the classical CA19-9 cancer biomarker. A second study with Hvidovre Hospital, University of Copenhagen in Denmark, demonstrated that a panel of two NuQ biomarker assays and the classical cancer marker CEA (carcino-embryonic antigen) in an age and gender adjusted panel detected 95 per cent (19 out of 20) of pancreatic cancers at 84 per cent specificity.

Professor Hermann Brenner, epidemiologist at DKFZ said, "VolitionRx has demonstrated some very encouraging early results for pancreatic detection using the Company's NuQ blood-based diagnostic tool. This larger trial with DKFZ will provide a more extensive opportunity to evaluate the effectiveness of Nucleosomics technology for pancreatic cancer diagnosis, a high-unmet medical need worldwide."

Dr. Mark Eccleston, VolitionRx's business development director, said, "We are delighted to be working with a world class institution such as DKFZ to advance our pancreatic cancer tests. Our preliminary studies indicate that NuQ tests can identify disease-associated nucleosomes in the blood of patients with pancreatic cancer, and differentiate those from healthy populations as well as those with other benign pancreatic diseases. Our goal at VolitionRx is to complete this trial by the end of this year and if successful, to begin the regulatory work to sell clinically in 2017, starting in Europe."

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 five-year survival rate for pancreatic cancer is currently just 7.7 per cent, due to late diagnosis and the aggressive nature of the cancer. Screening for this cancer is only currently recommended for individuals considered at high risk of developing pancreatic cancer, as the only available methods are expensive or invasive techniques. CA19-9, the only blood based biomarker for pancreatic cancer, has relatively low accuracy and is therefore used mainly for monitoring treatment response and disease progression. Despite this limitation, there are still over 46 million CA 19-9 tests performed in the US, UK, Germany, France, Italy, Spain and Japan annually. Either replacing or augmenting this test would be the first target for VolitionRx in bringing a pancreatic blood test to market.

VolitionRx's chief executive officer, Cameron Reynolds, added, "VolitionRx plans to launch its first commercial product, a blood test for colorectal cancer, later this year. Because our two preliminary trials for pancreatic cancer have produced such outstanding results, we anticipate this will be followed soon after by a NuQ panel test for pancreatic cancer. This trial with DKFZ allows us to expand our analysis very quickly, with results expected by the end of the year, in a large sample set with a world class institution. If successful, this would be a game changing breakthrough in the diagnosis of this very deadly cancer."

Results from on-going clinical trials assessing the effectiveness of VolitionRx's biomarker assays, include colorectal cancer and pre-cancerous colorectal adenomas.

Interim results from a 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark), released September 9, 2015: Panel of four NuQ biomarker assays detected 81 per cent of colorectal cancers at 78 per cent specificity and 67 per cent of high-risk adenomas.

Results from a completed prospective study of 121 patients referred for colonoscopy (CHU Dinant Godinne - UCL Namur, in Belgium), released December 8, 2015: Panel of four NuQ biomarker assays detected 91 per cent of colorectal cancer cases at 90 per cent specificity and also detected 67 per cent of high-risk adenomas.

Results from a retrospective study of 430 patients referred for colonoscopy (Hvidovre Hospital, University of Copenhagen, Denmark), released February 17, 2016: Panel of five NuQ biomarker assays demonstrated 75 per cent accuracy in detecting highest-risk pre-cancerous colorectal adenomas and also detected 86 per cent of early (stage I) colorectal cancers at 78 per cent specificity.

Results from a 59-patient retrospective study (Lund University, Sweden) published in Clinical Epigenetics online journal (http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf), October 7, 2015: Panel of four NuQ biomarker assays plus CA 19-9 classical biomarker detected 92 per cent of pancreatic cancers at 100 per cent specificity.

Interim results from a 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark), released October 22, 2015: Panel of two NuQ biomarker assays and the classical cancer marker CEA (carcino-embryonic antigen) detected 95 per cent of pancreatic cancers at 84 per cent specificity.

Results from a 537-patient retrospective study (Surrey Cancer Research Institute at University of Surrey, United Kingdom), released April 20, 2016 at the AACR Annual Meeting: A single NuQ biomarker assay detected 71 per cent of early stage I prostate cancer cases and 86 per cent of late stage IV prostate cancer at 93 per cent specificity, which is significantly higher than the commonly-used PSA test reported to detect 53 per cent of prostate cancers at 73 per cent specificity.

Interim results (73 of 240 patients collected and assessed) from a prospective study (Liège University Hospital, Belgium), released November 19, 2015: Panel of four NuQ biomarker assays detected 93 per cent of lung cancers at 91 per cent specificity and differentiated lung cancer from the common lung disease, COPD.

Results from a retrospective study of 78 patients referred for colonoscopy (Liège University Hospital, Belgium), released March 9, 2016: Preliminary data demonstrated 86 per cent accuracy in detecting Idiopathic Pulmonary Fibrosis, a fatal lung disease, at 80 per cent specificity.