Great New Companion Diagnostics E-Book Released Today

Monday, December 12, 2011

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.

Enjoy!

[UPDATE 12/16/12] The Kindle version of this e-book is now available for only $4.99.

Tags: CoDx, FDA, IVD, Industry

Share / Follow



Other Blog Authors

Dylan Reinhardt
Dave Kern
Steve Gutman
Jo-Ann Gonzales

Recent Blogs

Immediately in Effect Guidance In your role as a regulatory professional, chances are you have faced this situation
A First Look at a New Review Paradigm Working the bugs out of new methods for identifying bugs
FDA Announces New EUO Label Draft guidance will lay out new path for devices
Is Apple's Rumored Healthbook a Medical Device? Looking to re-invent the old "Apple a day" saying