[Infographic]: A Visual History of LDT Regulation

We’ve covered the LDT regulation evolution for some time now.  To give some perspective we’ve created the following infographic showing the history of LDT regulation.  To use it in your own content check out the code snippet below the infographic.  We only...

Is This a Big Opportunity for Diagnostic Test Developers?

Since the inception of this blog over 4 years ago, one of the key topics has been companion diagnostic testing for cytochrome p450 (CYP) mutations. Indeed this was the topic of the very first post. Testing for these mutations is increasing rapidly, but CYPs remain in...

73% Growth in the Use of Companion Diagnostic Biomarkers

– Metabolism biomarker testing dominates companion diagnostic (CDx) use – There is significant variability in reimbursement trends from state-to-state for CDx biomarkers – Rejected claims for CDx biomarker testing dropped by almost a third from 2013...

Is Personalized Medicine Being Properly/Fully Utilized?

An article published in Nature last month describes a recent trend in which “oncologists are starting to prescribe expensive new drugs that target the genetic profiles of their patients’ tumors, even when those treatments have not been approved for the particular...

Two New Personalized Medicines Approved by FDA So Far in 2015

I received a marketing circular last week from the organizers of the 2016 Personalized Medicine World Conference that included a message from the conference chair, Atul Butte, who made the following statement: “The high volume of targeted drugs recently approved...