Companion Diagnostics Play a Confusing Role with PD-1 Inhibitors

There are now three approved drugs that target PD-1 either directly or indirectly, and more are under development.While these drugs all seek to inhibit PD-1’s immune suppressive activity, they are quite different in the ways that companion diagnostic tests play a role in their use.

We collaborated with BIO and Informa on a ground-breaking study

We write a lot of blog posts and produce long form reports on various biomarker-related topics.  Those efforts have netted us several exciting collaboration opportunities.  Recently, we had the opportunity to contribute to the largest study of clinical trials success rates in collaboration with BIO ...

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 ...

Chart of the Week: Update: Unique Biomarkers in Pharma

On January 29th, we posted a CotW outlining the top 10 pharma companies by number of unique biomarkers those companies are using in trials.  We thought it was about time to update that chart and expand it to the top 25 pharma companies. Interesting facts to note:

Lawsuit a Catalyst for LDT Regulation Progress?

We have written extensively about health system regulation in this blog, with a keen interest in how LDT regulation will shake out.  In our other blog we've even argued strongly for caution in LDT regulation, primarily to avoid stifling innovation.  However, our tune is changing as more and more ...

Chart of the Week: Alzheimer's Biomarker and Trial Landscape

This week's CotW includes the landscape of biomarkers and clinical trials for Alzheimer's disease.  There is significant clustering around two biomarkers, but many interesting emerging biomarkers in clinical trials.

Precision Medicine Innovation Not Just a Numbers Game

We published a revision to our Precision Medicine Scorecard: Drug Company Edition last month. As John Audette rightfully notes, there are multiple factors in a pharmaceutical company's contribution to precision medicines:

Chart of the Week: Celgene Precision Medicine Activities Graph

We've been curious about Celgene's activity in precision medicine for some time.  We've posted blog posts here, here and here proposing that Celgene's activities are indicative of a precision medicine push.  As a supplement, this weeks CotW is a network graph of Celgene's clinical trial activity, ...

Biomarker Panels Explode in LDTs

by John Audette | May 04, 2016 | LDT Regulation, Innovators

In this blog we have regularly assumed (without hard data until now) that most biomarker innovation was taking place in laboratory-developed tests (LDTs) as opposed to tests cleared and approved by FDA, and we can now confirm that this assumption is correct.

Chart of the Week: Panel Opportunities in Lung Cancer

This weeks CotW is from our recent webinar.  This figure demonstrates the results of an analysis focused on identifying biomarkers that are measured together frequently in clinical trials.  The goal of the analysis was to identify groups of biomarkers that are linked by both co-occurrence in ...




Pharmacovigilance and Safety Biomarkers

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