Ready or not: personal tumor profiling tests take off.

O ne vital goal of cancer research is a test that profiles individual tumors at the molecular level in order to guide treatment. Some single-marker predictive tests are now standard, as are two well-validated genomic prognostic tests for breast cancer. But for most tumors, such personalized tests are still viewed as futuristic. At a recent cancer molecular diagnostics conference, many genomic test methods were presented, all of them strictly experimental. But since 2008, unknown to most oncologists and their patients, three companies have introduced commercial tests that provide genomic profi les of individual patients ’ tumors. Along with the profi les, the companies include a list of drugs whose effi cacy has been associated, on some level, with the molecular features of each tumor. Marketing materials describe the tests as tools to help oncologists choose appropriate drugs or drug combinations. These tests have gone largely unnoticed because the companies have relied mainly on limited direct marketing to oncologists and word of mouth for publicity. Only one company has published clinical results in a scientifi c journal. And because the labs that perform these tests are certifi ed under the federal Clinical Laboratory Improvement Amendments (CLIA), the tests do not require U.S. Food and Drug Administration approval to be sold. Fewer than 13,000 cancer patients have used them. Unlike the “direct to consumer” genetic tests that assess risk for disease, results for these tests go fi rst to a doctor. But they have not yet proven better at guiding cancer treatment than standard methods. Their effectiveness has not been validated, and no randomized trials have taken place. Claims for their worth hinge on the argument that molecular profi ling information should translate to better treatment decisions, but no one knows yet whether that assumption is true. Critics argue that the tests should be used only to direct patients to clinical trials until the tests prove utility in their own randomized clinical trials. Such trials are planned, but these companies aren’t waiting.