The Companion Diagnostics Dilemma
This article was originally published in RPM Report
An Institute of Medicine workshop on companion diagnostics suggests that regulatory standards are evolving at FDA to encourage companion diagnostic development. But almost everything else is still a challenge.
You may also be interested in...
FDA is hoping to set up yet another user fee program—this one for lab-developed test oversight—when the next user fee legislation is enacted in 2017. The labs aren’t ready to negotiate yet, but the issue is going to be an important area for biopharma to monitor as the transition to personalized medicine continues.
CMS is emphasizing coverage of companion diagnostics as a key role it can play in advancing personalized medicine. A couple of add-ons to this year’s “Doc Fix” legislation may help move that effort forward.
While the genetics firm is not wavering in its legal effort to protect its BRCA gene testing dominance, it is diversifying in response to inevitable competition, with a focus on a multigene panel and companion diagnostics.