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...

CMS Plan for Test Pricing Seems to Favor Large Labs

Nov 1, 2015 | News

CMS has finally released its plan for market-based reimbursement of lab testing, and early reaction from industry seems to be that large test providers such as Quest and LabCorp will benefit most from the new system. The new system requires that “applicable...

Regulatory Delays Are Keeping the Diagnostics Industry in Limbo

Jul 10, 2015 | News

An FDA official recently stated that the final version of the draft guidance regarding regulation of laboratory-developed tests (LDTs) is not likely to be released before the end of this year. Elizabeth Mansfield, director of personalized medicine at the FDA’s...