Oncologists Struggle to Utilize Precision Medicine

The challenges faced by oncologists in using biomarker-based tests were underlined in a recent article by Dr. Marcus Neubauer in OncLive.

FDA and CMS Have Formed a Joint Task Force for LDT Co-Regulation

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

FDA and CMS have just announced that the agencies are forming a joint task force to explore "areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories." This is a laudable effort that should ensure a minimum of ...

Tackling Ovarian Cancer's Most Urgent Unmet Need: Ten Years and Counting for One Research Team

A new method for prognosing ovarian cancer was recently described by researchers from the University of Utah. While I am particularly interested in precision medicine developments for ovarian cancer, as it is an especially under-served disease, I am not actually pointing out this development ...

LDT Biomarker Panels: A First Look

Having recently conducted an analysis of biomarker panels in FDA-approved tests, we are now beginning to analyze biomarker panels in laboratory-developed tests (LDTs). To my knowledge this is the first publicly available analysis of LDTs.

Which Biomarkers Are Relevant? Making Sense of the "Incidentalome"

by John Audette | Apr 08, 2015 | Development, News

An interesting recent article in Genetic Engineering News describes the challenges of making sense of biomarkers of unknown relevance that surface from whole genome sequencing (WGS). Such biomarkers are becoming common enough that there is even a name for them: the "incidentalome," (drawing on the ...




Pharmacovigilance and Safety Biomarkers

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