Interim results from VolitionRx’s first asymptomatic colorectal cancer (CRC) frontline screening study assessing it’s Nu.Q panel, 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% and was able to detect 80% of Stage I CRC cases and 66% of High-Risk Adenomas (HRA) at 78% specificity, respectively. 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.
"These interim results are encouraging, particularly for detecting early-stage colorectal cancer and potentially pre-cancerous adenomas,” said Hans Jorgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark. “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 VolitionRx 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."
In the study, blood samples were taken from 579 asymptomatic subjects, who participated in the Danish National CRC Screening Program. These included: 51 subjects who tested positive in the screening program for FIT and who were subsequently diagnosed with Stage I CRC at colonoscopy, 67 subjects who tested positive with the fecal immunochemical test (FIT) and who were subsequently diagnosed with HRA at colonoscopy, and 461 control subjects who tested negative with FIT.
The blood samples, which were collected according to a validated Standard Operation Procedure, were assayed by ELISA and the results analysed using Logistic Regression. Both age and smoking were included as patient variables. All assay results were highly statistically significant for both Stage I cancer and HRA detection. The panel reported includes two proprietary assays and one non-proprietary assay.
"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, “ said Cameron Reynolds, Chief Executive Officer of Volition. “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 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."
In the US, VolitionRx 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. VolitionRx 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 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 assays to be tested," said Dr Jake Micallef, VolitionRx'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 Frontline Asymptomatic Colorectal Cancer Screening Test could be available for sale in the EU later this year."