Yes, President Obama’s new $215 million Precision Medicine Initiative supports important science, but it also bolsters biotech branding in a way the science doesn’t always support.
To understand why clinical genomics (a more neutral descriptor) isn’t quite as reliably precise as backers like to boast, consider three tests meant to determine whether a certain type of breast cancer will recur. The tests can help avoid the physical and emotional costs of unneeded chemotherapy.
An analysis by BiomarkerBase found that just 12 of the 125 biological targets used by these competing tests are shared, and no one gene is used by all three. More importantly, results of the three – Genomic Health’s Oncotype DX, Agendia’s Mammaprint and Prosigna from nanoString Technologies – often disagree.
As an article in the journal Tumor Biology put it, these assays
differ in the technological platforms used for assessment of gene expression, in the number of genes and in the specific genes that are being tested, in the patient populations used for their development and validation, and in their clinical utility.
Precision, anyone?
Pay particular attention to “validation” and “clinical utility;” i.e., evidence the tests help patients. Breast cancer is a deadly serious problem, accounting for between a quarter and a third of all cancer cases, and it is the second-leading cause of cancer-related deaths. But like other cancers, it’s also complex, with the prognosis depending upon the mix of molecular subtypes and other patient-specific factors.
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