Why do cancer biomarkers keep failing to perform?

Cancer experts have repeatedly been frustrated by the failure of once-promising biomarkers for the disease. So Mount Sinai Hospital's Eleftherios Diamandis, professor of pathology and laboratory medicine, set out to determine exactly what went wrong.

Taking a look at seven frustrating cancer biomarkers that emerged over the past 25 years--including nuclear magnetic resonance of serum for cancer diagnosis and lysophosphatidic acid for ovarian cancer--Diamandis discovered a broad range of issues, from inappropriate statistical analysis to biases in case patient and control subject selection.

"Problems with pre-analytical, analytical, and post-analytical study design could lead to the generation of data that could be highly misleading," concludes Diamandis in an article published online August 12 in The Journal of the National Cancer Institute.

"Unfortunately, diagnostics are different from therapeutics," Diamandis notes in a follow-up discussion with Time. "When a therapeutic comes out, to get to the patient, as you know, there are very stringent criteria. Therapeutics have to get FDA approval. They have to do Phase I, Phase II and Phase III trials, so there's a very well defined roadmap. The diagnostics business is very different because we don't have these stringent phases that people have to go through to make their case. If somebody says I measured this, in this patient, and this thing goes up or down, you can publish without too much difficulty. It's only when something is published that other people say, okay, let's see if it's going to work. If it doesn't work then we find out three years later. But eventually we will find out."

- here's the Journal of the National Cancer Institute release
- read the Time's Q&A