No doubt about it, companion diagnostics is one of the hot topics of 2011. In just the past six months or so, we've seen two high-profile CoDx approvals (BRAF and ALK), several instructive non-approvals and the publication of a valuable guidance document from FDA. This year, it wasn't just the leading-edge pharmas seeing the potential of CoDx… now it's pretty much the thing everyone in industry is talking about.
Even so, there's just not that much good information available. Those of us who have worked on these applications are frequently held under strict confidentiality and the field is still new enough that several of the people speaking about CoDx at conferences still haven't been involved in a CoDx application. You know who you are.
That's why we jumped at the chance to sponsor a Fierce Medical Devices e-book on this important subject. There's been a real absence of reliable, public information to date and Fierce is perfectly positioned to give this subject the long-form treatment it deserves. We even pitched in a couple articles to share some of the experience we've had.
We're pleased to join Fierce in announcing that this e-book is now available for download. We've heard that they may also publish a version for Kindle and other e-readers.
[UPDATE 12/16/12] The Kindle version of this e-book is now available for only $4.99.