VolitionRx Limited has announced interim results from its first asymptomatic colorectal cancer (CRC) frontline screening study. This ongoing study is being carried out in collaboration with Hvidovre Hospital, University of Copenhagen, Denmark and involves 680 subjects from the Danish National CRC Screening Program. The interim results demonstrated that a small panel of three ELISA assays, when considered with the subjects' ages and smoking histories, produced an area under the curve (AUC) of 83 percent and was able to detect 80% of Stage I CRC cases and 66 percent of High-Risk Adenomas (HRA) at 78 percent specificity, respectively.
Cameron Reynolds, chief executive officer of Volition, commented, "After seven years of hard work, we are happy to announce these excellent early detection interim results from our ongoing front-line screening trial for colorectal cancer. Using only a small panel of three assays and considering certain limited patient variables, these data demonstrate that we can identify early stage and pre-cancerous adenomas at a high level of accuracy in an asymptomatic screening environment. Our tests use only a small amount of blood and could be added to routine blood screening regimens at a reasonable cost. We believe these are the first data to show high detection rates in a blood test, not only of early Stage I cancer, but also of the extremely important high-risk pre-cancerous adenomas. We believe that with further development, our Nu.Q(TM) panel could form the basis of new CRC tests with early stage disease detection, and that our tests could become accessible to and usable by a wide section of the screening population around the world."
Hans Jorgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark, commenting on these findings said, "These interim results are encouraging, particularly for detecting early-stage colorectal cancer and potentially pre-cancerous adenomas. Most blood-based cancer biomarkers are more effective at detection of large late-stage cancers than small early-stage cancers, and very poor at detecting pre-cancer. Certainly, these results need to be validated in larger and representative cohorts, which Volition plans to do initially in a 4,300-subject study and subsequently in a 12,000+ double blinded study, using samples collected at 10 collaborating Danish hospitals."
CRC is one of the most preventable cancers, yet it currently remains the least prevented form of cancer. The American Cancer Society Cancer Facts and Figures 2018 report provides that the five-year survival rate for CRC at all stages is 65 percent; however, the survival rates differ significantly depending upon the stage at diagnosis: only 14 percent of patients diagnosed at Stage IV survive more than five years, whereas 90 percent of those diagnosed at Stage I survive more than five years. This clearly underscores the importance of early detection. Moreover, while not included in the Facts and Figures report, it is widely believed that diagnosis of pre-cancer conditions like HRA and High-Grade Dysplasia can result in cancer-free survival.
In the US, Volition is participating in what is believed to be the largest ever CRC screening study in collaboration with the National Cancer Institute's Early Detection Research Network with a cohort of over 13,500 subjects. Collection is underway and is expected to be completed in 2020. The objective is to build upon the European studies to refine test performance and to present final data to the FDA prior to completion of the study. Volition expects to define the final panel for the US front-line test within the next 18 months.
"We have now embarked with confidence on our next stage of assay development to further validate these assays, and ultimately our Nu.Q(TM) Frontline Asymptomatic Colorectal Cancer Screening Test. This will be run in parallel with ongoing work in our 680-sample set, which still has more Nu.Q(TM) assays to be tested," said Dr. Jake Micallef, Volition's chief scientific officer. "This next stage of development is a 4,300-subject training study, which will determine the final locked down panel (which we expect to be 5-6 assays), the results of which we hope to report in the second quarter of 2018. We will then conduct a large, 12,000+ subject validation study, which we hope to begin in the second half of 2018, which will form the basis of our EU product claims. In parallel, we are progressing towards obtaining a CE Mark for this panel so that the Nu.Q(TM) Frontline Asymptomatic Colorectal Cancer Screening Test could be available for sale in the EU later this year."
Professor Stefan Holdenrieder, Director of the Institute of Laboratory Medicine of the German Heart Center at the Technical University of Munich, Germany and a widely published expert in the field of circulating nucleosomes added, "Given these very interesting results in early cancer detection, we are very much looking forward to the upcoming results of the 27-cancer study that will follow the ongoing CRC studies. This study will analyze the performance of the Nu.Q assays in the most prevalent cancers, and it will test the depth of Nucleosomics as a platform technology beyond CRC in other major cancers."