VolitionRx (NYSE American:VNRX) announced interim results from its first asymptomatic colorectal cancer (CRC) frontline screening study in collaboration with Hvidovre Hospital, University of Copenhagen, Denmark, with 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’ histories, produced an area under the curve of 83% and was able to detect 80% of Stage 1 CRC cases and 66% of high-risk adenomas at 78% specificity, respectively.
“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,” Cameron Reynolds, CEO, said in a statement.
Mr. Reynolds said the company believes these are the first data to show high detection rates in a blood test, not only of early Stage 1 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,” he added.
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.
Dr. Jake Micallef, Volition’s CSO, said using samples collected at 10 collaborating Danish hospitals, a 4,300-subject training study will determine the final locked down panel, which is expected to be five-to-six assays. Results are expected in the second quarter of 2018. A large, 12,000-plus subject validation study is expected to begin in the second half of 2018 and will form the basis of the company’s 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,” he added.
In the U.S., Volition is participating in what is believed to be the largest ever CRC screening study in collaboration with the NCI’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 on 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 U.S. front-line test within the next 18 months.
Prof. Stefan Holdenrieder, director of the Institute of Laboratory Medicine of the German Heart Center at the Technical University of Munich, said that given the 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.”
He said the study will analyze the performance of the Nu.Q assays in the most prevalent cancers, and will test the depth of nucleosomics as a platform technology beyond CRC in other major cancers. Data is expected from this trial in 2018.
