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Posts From the monthly archives: "April 2015"

The challenges faced by oncologists in using biomarker-based tests were underlined in a recent article by Dr. Marcus Neubauer in OncLive. In recent posts in this blog I have focused on the challenges of interpreting genomic data, but Dr. Neubauer emphasizes two additional and highly relevant points. The first is that just selecting the…(Read More)

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 overlapping regulation. FDA has played a central role throughout…(Read More)

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 “incidentaloma” concept from radiology, and perhaps first coined in a…(Read More)

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. Utilizing a proprietary data gathering and filtering tool, we pulled down the test menus from the public websites…(Read More)