Debating diagnostics

Instead of perpetuating a decades-old dispute about whether FDA can and should regulate laboratory-derived tests, the agency and test makers have moved on to conversations about how FDA should do so, and from threats of litigation to lobbying. This shift represents progress, and is a sign that there is hope for agreement on a scheme to replace a regulatory framework that was created before anyone had even conceived of technologies that are routine today.

Central to the debate are differing opinions about how best to promote innovation of technologies that are at the heart of personalized medicine while safeguarding the interests of patients. ...