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Lp-PLA2: Evolution of a Biomarker

This article was originally published in Start Up

Executive Summary

Pharmaceutical companies are increasingly experimenting with biomarkers in order to improve results of their clinical trials. Diagnostics companies are ideally suited to help, but pharma tends to shun them and diagnostics companies perceive that when both sides work together, the diagnostics side has less leverage. Here's how diaDexus believes it can retain clout as it works with GSK on a promising new diagnostic and therapeutic target: Lp-PLA2 for cardiovascular disease.

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Biomarkers are being used now across the whole pharmaceutical value chain, but it's unlikely we'll see a surge in the number of VC-backed biomarker discovery start-ups until the business models are proven.

GSK and diaDexus' Rx-Dx Partnership Model

Drug firms don't have a firm grasp of the development of biomarkers or their potential role in clinical decision-making. Nor have they, with few exceptions, looked to the diagnostics industry for help-they've been unwilling to outsource activities related to highly proprietary drug development projects. Moreover, traditionally, drug and diagnostic company alliances haven't fared well because both parties have different value expectations. Small diagnostic companies want biotech-like prices for their contributions; pharma marketers often see diagnostics as limiting to their sales efforts, and certainly something that can take attention away, in a 30-second detail call, from the main event-the higher-priced drug. But an eight-year-old alliance between British drug maker GlaxoSmithKline PLC (GSK) and diaDexus Inc. seems to address these barriers with some novel approaches now starting to bear fruit.

GSK and diaDexus' Rx-Dx Partnership Model

Drug firms don't have a firm grasp of the development of biomarkers or their potential role in clinical decision-making. Nor have they, with few exceptions, looked to the diagnostics industry for help-they've been unwilling to outsource activities related to highly proprietary drug development projects. Moreover, traditionally, drug and diagnostic company alliances haven't fared well because both parties have different value expectations. Small diagnostic companies want biotech-like prices for their contributions; pharma marketers often see diagnostics as limiting to their sales efforts, and certainly something that can take attention away, in a 30-second detail call, from the main event-the higher-priced drug. But an eight-year-old alliance between British drug maker GlaxoSmithKline PLC (GSK) and diaDexus Inc. seems to address these barriers with some novel approaches now starting to bear fruit.

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