A blood test developed by VolitionRx has detected 80% of stage 1 colorectal cancers in a screening study.
VolitionRx’s data come from an interim review of a study of more than 500 subjects in Denmark. Each of the asymptomatic participants in the study provided a blood sample for analysis. When VolitionRx analyzed the test results alongside the age and smoking histories of the participants, it detected 80% of stage 1 colorectal cancer cases and 66% of precancerous, high-risk adenomas at 78% specificity.
Detecting colorectal cancer early sharply increases the likelihood of a person surviving for more than five years. Today, healthcare systems test stool samples for blood or DNA to screen patients for the cancer. Cologuard, the DNA test, won FDA approval on the back of data showing it detected more than 90% of all colorectal cancer cases and almost as many cases of stage 1 disease.
Interim data on VolitionRx came in below that level. But VolitionRx’s detection of high-risk adenomas was very respectable, its test is still being improved and its reliance on blood samples, rather than stool samples, potentially gives it an edge in colorectal cancer screening.
“Our tests use only a small amount of blood and could be added to routine blood screening regimens at a reasonable cost,” VolitionRx CEO Cameron Reynolds said in a statement. “We believe that with further development, our Nu.Q panel could form the basis of new [colorectal cancer] 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.”
VolitionRx needs to refine its test and generate more data to get it established on screening programs. Work to gather that evidence is already well underway.
The next readout will come from a 4,300-subject study that aims to determine which assays to include in the final panel. VolitionRx expects to add two to three assays to the three-assay panel it used in the trial that reported data this week. Data from the 4,300-subject study are due in the second quarter.
Once VolitionRx has data from the trial it will step up work on a double-blind 12,000-subject study. The goal is to get that trial underway in the second half of the year. If all goes to plan, data from the trial will support product claims in Europe, where VolitionRx hopes to get CE marked this year. The company is also working to bring the test to market in the U.S.