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Thermo Fisher, Proteome Sciences Form Biomarker Alliance

Thermo Fisher Scientific today said that it will collaborate with Proteome Sciences to develop quantitative proteomic workflows for biomarker discovery and validation.

FDA Delays Release of Guidance on Biomarker Qualification; Aims to Publish by End of Year

The US Food and Drug Administration has delayed the release of its draft guidance on the biomarker qualification process.

Originally slated to be released this summer, the guidance – which will detail the formal steps involved in qualifying biomarkers for FDA approval – will now be put out sometime “before the end of the year,” Federico Goodsaid, associate director for operations in genomics at FDA, told ProteoMonitor.

Duke, LabCorp Launch ‘Factory’ to Translate Biomarkers into Personalized Medicine Tests

If a factory is where raw components are manufactured and assembled into commercial products, then why not take a similar approach to developing diagnostics to predict disease predisposition and response to drugs?

Duke University and the Laboratory Corporation of America have put their collective expertise together to create just such an enterprise, which they’ve dubbed the Biomarker Factory. The project, announced earlier this month, enjoins Duke University Medical Center’s expertise in biomarker discovery and LabCorp’s capacity to develop laboratory-developed tests from validated biomarkers.