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Bench to bedside

Formulating winning strategies in molecular diagnostics


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Each day brings new headlines of scientific discovery. The first report on microarray technology appeared in Science just over a decade ago. But until recently, microarray technology had been burdened with issues of reproducibility and standardization, preventing its use in clinical applications. Belying this is the promise of molecular therapeutics – the “holy grail” of cancer research, translation and therapy – which could target the underlying defects leading to disease. Many have put their hope into novel genomic technologies which are rapidly driving the development of molecular diagnostics to optimize drug therapy and companion diagnostics as a method to better define a patient’s need or predict clinical outcome from a specific drug.

This presents an opportunity to not only bring novel scientific innovation to patients, but also an opportunity for companies which have historically focused on the scientific research market to bring their products directly to the healthcare market. The payoff for successful molecular diagnostic products can be significant; Kalorama Information predicts that this market currently exceeds $3.2B worldwide and will reach $5.4B in four years, both by increases in the number of commercially available tests and the increase in adoption of use in a clinical setting.

This article is a Deloitte Point of View on the opportunities and key requirements for commercial success in the emerging markets of molecular diagnostics. This point of view is specifically relevant to analytical instrument companies, research tools companies, and others focused on making products for the academic and commercial R&D labs, seeking to transition into molecular diagnostics markets. In addition to retaining technological superiority, such companies will also need to significantly enhance their core commercial capabilities in order to capitalize on the growth in the Molecular Diagnostics markets.

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As used in this document, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.

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