VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced that it has accelerated its large independent prospective study evaluating its proprietary Nucleosomics® platform at University Hospital Bonn in Germany. VolitionRx has dedicated two of its recently-procured Tecan EVO200 automated laboratory robots to the study, with sample analysis to begin early in the third quarter of 2015. In addition, VolitionRx and study lead Prof. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn in Germany have increased the sample size and breadth of cancer types being tested.
The study initially included 4,000 patient blood samples across 20 of the most prevalent cancer types, and has now been expanded to include approximately 4,200-patient blood samples across 27 of the most prevalent cancers, including: two types of respiratory cancer, seven types of gastrointestinal cancer, four gynecological cancers, four urinary cancers, four types of hematological cancer, plus melanoma, sarcoma and cancers of the thyroid and brain; as well as control patients with 24 other conditions and healthy individuals. In total, the cancer types being analyzed represent over 95% of the incidence of cancer.
Dr. Jake Micallef, VolitionRx’s Chief Scientific Officer, said:
This trial is an incredibly important one, which we hope will show the breadth of our Nucleosomics® technology. The trial is not only essentially 27 pilot studies in the most common cancers, but we are also looking for differences between cancers, and between cancers and other diseases, to discover if a panel of assays can detect several cancers from the same blood draw. We are grateful to Prof. Holdenrieder for his commitment to this ongoing multi-year trial, demonstrated by the increase of sample size and broadening of cancer types being evaluated in the trial – both of which we hope will enable us to more clearly demonstrate accuracy rates of our NuQ® test in these patient populations.
Cameron Reynolds, Chief Executive Officer of VolitionRx, commented:
We are very excited that with the addition of two fully-operational automated robot systems, analysis of the full 4,200 sample collection is on track to begin early in the third quarter of 2015. We expect to analyze the samples with up to 10-15 NuQ® assays by the first quarter of 2016. The aim of the trial is both to evaluate a large number of cancers and to look for a panel of assays that can diagnose multiple cancers for potential new products beyond the current four cancers we are evaluating.
Prof. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn in Germany, who is leading the study, added:
Collectively, cancer is one of the foremost causes of mortality around the world and there remains a significant global need for improved early cancer detection. An accurate and non-invasive test using only a drop of blood that could detect a range of cancers would provide physicians and patients an opportunity to treat the disease early on, before the cancer metastasizes, providing greater chances of survival. Collection and analysis of samples has been, and will continue to be, carried out in my laboratory with VolitionRx providing the assays for analysis. I am very much looking forward to seeing the results from this study.
The NuQ® tests utilize the Company’s proprietary Nucleosomics® technology platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer and signals within the blood.
Clinical trials assessing the effectiveness of VolitionRx’s assays include:
- A 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark)
- A 14,000 patient prospective screening study (Hvidovre Hospital, University of Copenhagen, Denmark)
- A 250 patient prospective study (CHU-UCL Mont Godinne Hospital, Belgium)
Pre-cancerous colorectal adenomas:
- A 800 patient prospective study (Hvidovre Hospital, University of Copenhagen, Denmark)
27 most prevalent cancers
- A 4,200 patient prospective study that involves patients with the 27 most prevalent cancers (University Hospital, Bonn, Germany)
- A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany)
- A retrospective study to establish the efficacy of VolitionRx’s NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas)
- A 120-patient prospective feasibility study (ImmuneHealth, Belgium)
- A 40-patient prospective feasibility study (Singapore General Hospital, Singapore)
- A prospective study to assess VolitionRx’s NuQ® tests for the diagnosis of endometriosis (the University of Oxford, United Kingdom)