Tuesday, June 4, 2013

FDA To Act on LDTs?

As noted in this Forbes article, a recent ASCO meeting became the occasion for FDA commissioner Margaret Hamburg to suggest that the agency is judging some of the LDT cancer tests to be too important to medical decision making not to regulate.

LDTs, or lab developed tests, are performed not in a hospital lab or physician office.  They are sent out to central labs so they generally fall out of FDA's rules.  In the past, LDTs were used within a hospital system, one lab, a few physicians.  But as certain labs become known for tests, they are seeing broader usage and the companies that perform tests are seeing a healthy business. 

Commissioner Hamburg cited the example of OvaSure, which was marketed as a test to detect ovarian cancer   but was withdrawn from the market four months after it was launched because oncologists and the FDA found it was not effective.

Kalorama's report on this topic, The World Market for Cancer Diagnostics,

is the fifth time Kalorama's analyst Shara Rosen, MBA, R.T. has taken a serious look at this market.  The report discusses LDTs and other trends, has revenue figures for key companies and forecasts the market.