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Molecular Diagnostics: A Dynamic and Rapidly Broadening Market

Below is an excerpt from an interview in the new Insight Pharma Report, Molecular Diagnostics: A Dynamic and Rapidly Broadening Market. For a complete Table of Contents for this report, please go to http://www.insightpharmareports.com/reports_report.aspx?r=6647&id=87360.

Matt Winkler, PhD
Chief Executive Officer and Chief Scientific Officer, Asuragen, Austin, TX

CHI: What are your opinions on the role of molecular diagnostics and personalized medicine?

Dr. Winkler: It clearly will be a dramatically expanding opportunity for diagnostic companies and a challenge for the medical community to integrate this into ordinary medical practice. My sense is that consumers who understand this technology would like access to their genetic/molecular information to make more effective healthcare decisions. It is probably more hype today than reality, but the reality is coming fast.

Probably the single most disruptive element in molecular diagnostics will be the advent of extremely low-cost sequencing. It will change the face of the diagnostics industry. Many assays are now performed on a variety of different platforms that could all be done by sequencing. For example, array-based tests in theory could all be performed more effectively by sequencing. Presently, it is still less expensive to run microarrays. However, as the price of sequencing continues to fall, microarrays will be replaced by next-generation sequencing. Name a molecular biology–based assay, and I can probably tell you how next-generation sequencing will be able to do the assay better at some point in the future. For now, it is simply too expensive. The price of sequencing is falling much faster than Gordon Moore [cofounder and former Chairman and CEO of Intel Corporation] would have predicted.

CHI: What do you perceive to be the greatest challenges or hurdles for companies developing and marketing molecular diagnostic tests?

Dr. Winkler: One of the challenges is the tightening of FDA regulations regarding what constitutes an ASR and the requirement to take tests forward as IVDs. A problem is that market sizes for some tests will simply not be large enough to justify getting FDA approval for the test. That is a challenge that all of the smaller molecular diagnostic companies are facing.

CHI: What do you perceive to be the greatest changes in the field of molecular diagnostics in the near future?

Dr. Winkler: Related to this issue of market size and IVDs, as molecular diagnostics advances, it will identify tests that provide clinically relevant information, but to progressively smaller and smaller markets. When you start to talk about rare familial mutations, the number of affected people might be quite small, but that information is very clinically relevant to that small group. Yet the economics will not make sense. Thus, there will have to be an evolution in how this area is regulated.

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