In February of last year the FDA hosted a two-day workshop focused on technical and regulatory considerations related to the use of next generation sequencing (NGS) diagnostics in clinical practice.  This was a very forward-thinking move on the part of FDA, as clinical NGS is advancing rapidly and ...

Orginally posted on LinkedIn An interesting article was published today in the Journal of Precision Medicine describing the importance of testing psychiatry patients for mutations in two companion diagnostic biomarkers, CYP2D6 and CYP2C19. These are indeed important biomarkers for safe ...

Last week we posted an analysis of the growth rates and market caps for companies that develop IVD tests (which was in itself a follow-up to some analyses from a couple of years ago).  This week we are presenting the same analysis for developers of lab-developed tests (LDTs).  On both of the ...

The news this week that CMS may reduce rates for some molecular diagnostic tests (by over 70% in a couple of cases) stimulated the idea of taking a quick look at the current market dynamics for diagnostic test developers.

There are now three approved drugs that target PD-1 either directly or indirectly, and more are under development.While these drugs all seek to inhibit PD-1’s immune suppressive activity, they are quite different in the ways that companion diagnostic tests play a role in their use.