The First Ever Blood Biomarker For Multiple Sclerosis Discovered.

Huge news coming in the world of health and science as the first ever blood biomarker for Multiple Sclerosis (MS) has been discovered.

Chart of the Week: Over 700 Unique Biomarkers in 2015 Clinical Trials

Last week our chart of the week was a look at the total number of clinical trials started annually that include biomarkers, with a projection out to 2020.  The hockey stick shape of the growth rate was striking, so much so that we decided to follow-up and ask the question: are there actually new ...

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.

FDA Finally Provides Better Evidence of LDT Risks

by John Audette | Nov 16, 2015 | LDT Regulation, News, Regulation

For a long time now I have been pushing FDA to provide evidence to back up its claim that LDTs have introduced risk to patient populations. That evidence has now been provided, and it is compelling.

Upcoming Congressional Hearing on Lab Test Regulation

by John Audette | Nov 04, 2015 | LDT Regulation, News, Regulation

The U.S. House of Representatives Committee on Energy and Commerce is holding a hearing entitled "Examining the Regulation of Diagnostic Tests and Laboratory Operations" on November 17 at 2pm ET (note that the date was re-scheduled from an earlier date).




Pharmacovigilance and Safety Biomarkers

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