Our study is the clinical validation of a new and novel blood-based test for average-risk colon cancer screening.

What was the study design?

The study design was that we recruited adults between the ages of 45 to 85 across the US at 200 centres who were average risk for colorectal cancer. These individuals were scheduled for a screening colonoscopy. Prior to their screening colonoscopy they underwent a blood draw and that sample we used in a blinded fashion to clinically validate this novel blood-based test to see how it performs in terms of accuracy in predicting colorectal neoplasia.

What were the results of this study?

The results of the study were that the study met all its primary endpoints. The sensitivity of this blood test for detecting colorectal cancer was 79.2%. The specificity of the test for detection of advanced colorectal neoplasia was 91.5%. The negative predictive value for advanced colorectal neoplasia was 90.8% and the positive predictive value for advanced colorectal neoplasia was 15.5%.

What do you think is the clinical significance of these results?

The clinical significance of these results is that this test appears to perform adequately in detecting colorectal neoplasia in average-risk individuals and this can potentially be a convenient and effective option for screening for colorectal cancer. Combined with other modalities that we use for colorectal cancer screening, this could actually help us boost adherence to colon cancer screening so that we can prevent the long-term sequalae of it.

What is next for this study?

The next steps for the study are to submit these data to regulatory bodies, including the FDA, for approval of the test followed by submission to CMS for reimbursement and also further studies to refine the assay so that it can be even further optimised for detection of colorectal neoplasia.