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Biomarker Intelligence Management - Process (Part 2 of 5)

Three weeks ago we introduced the concept of the Biomarker Intelligence Maturity Model where we unveiled the 5 stage, 4 swim-lane model representing how companies improve biomarker intelligence management to win in drug and diagnostic development. This is the second installment of that series where ...

FDA Regulation to Support the Next Wave in Diagnostics

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 ...

Precision Medicine Focus: Psychiatric Biomarkers

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 ...

Dx Test Developers Experience Declining Revenue Growth

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.

New Releases Do Little to Clarify FDA's Definition of Complementary Diagnostics

Some time back, FDA alluded to a new category of biomarker termed "complementary diagnostic."  This was the Agency's first use of a categorization beyond "companion diagnostic." Since then there have been several public announcements of new "complementary diagnostic" tests, or expanded indications ...

   

December

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