New cancer test isn’t ready for prime time
Author: H Gilbert Welch Date: February 14, 2018 Source: http://www.cnn.com/2018/02/13/opinions/liquid-biopsy-opinion-welch/index.html (CNN)- A simple blood test to detect cancer early. How great is that? There has been enthusiasm about the so-called "liquid biopsy" for years. In mid-January, however, doctors learned more -- both about this vision and its problems. A widely reported study in the journal Science described a liquid biopsy test -- CancerSEEK -- which combined measuring eight tumor biomarkers with testing for pieces of DNA with cancer associated mutations in 16 genes. It's not one test; it's a battery of tests. And while collecting the blood may be simple, the subsequent analysis is extraordinarily complex. The task at hand is particularly challenging. We all have pieces of DNA in our blood. Distinguishing the tumor DNA from the background DNA requires finding the mutations specifically associated with cancer. Adding to the complexity, healthy individuals can have mutations. To avoid labeling innocuous mutations as cancerous requires a bunch of statistical fine-tuning. In other words, there are a lot of steps in a liquid biopsy and much potential for things to go awry. To their credit, the CancerSEEK investigators were very forthright that the study conditions were ideal for the test to accurately detect cancer. The liquid biopsy simply had to discriminate between patients with known cancer (the majority of whom had symptoms) and healthy individuals. And the statistical fine-tuning was tailored to the study participants -- with the knowledge of who had, and who did not have, cancer. Although the test was [...]