Friday, February 9, 2007

Big news that's easy to miss -- FDA clears a molecular prognostic tool for breast cancer metastasis

The FDA just approved a prognostic device. So what's the big deal?

I'll let the press release speak:

It is the first cleared molecular test that profiles genetic activity.

That's right. Despite many years (ok, about a decade to a decade and a half) of use in basic research, microarray technology has matured (along with the analysis methodologies) enough to be used in clinical practice, and this approval marks a big step toward that. Microarrays were a buzz in the statistical community a few years ago when there were still some methodological hurdles to overcome (and were being rapidly overcome).

What's more, this marks the first time a genetic expression test (different from a genetic test -- this one identifies which genes are expressed [active] at a particular time) has been approved for the prognosis of a disease. 70 gene expressions are analyzed. Agendia has blazed some trails, and I expect to see more of this kind of test in the coming years. And that's a good thing.

And, hopefully for women with breast cancer, this will help a bit in the decision making for treatment.