FDA Regulation to Support the Next Wave in Diagnostics

Jul 12, 2016 | News

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...

Precision Medicine Focus: Psychiatric Biomarkers

Jul 1, 2016 | Biomarkers, News

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...

Dx Test Developers Experience Declining Revenue Growth

Jun 15, 2016 | News

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. For this week’s post we decided to...