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Expanding Molecular Diagnostics

By Lucy Sannes

March 24, 2009 | Insights Outlook | Molecular diagnostics comprise a large segment of the overall in vitro diagnostics industry. Worldwide clinical sales in 2008 for kits and reagents sold by diagnostic companies amounted to approximately $3 billion or more. Additionally, many molecular diagnostic tests available today are not sold as kits or reagents but are laboratory developed tests offered as a testing service by clinical laboratories and/or by diagnostic companies with their own Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for performing their proprietary tests.

Insight Pharma Reports sat down with James White, CEO of Osmetech (Pasadena, Calif.) to discuss the newer applications of molecular diagnostics, marketplace trends, and considerations for companies in this space.

Insight Pharma Reports (IPR): What are your thoughts on the role of molecular diagnostics and personalized medicine?
White: When you look at the growth rates for molecular diagnostics, in the 15% to 20% range, pharma companies are getting involved. Every new drug they launch has a diagnostic alongside it that has not been factored into the growth rate. What you are seeing is the trend of the pharma personalized medicine numbers adding to the growth rate. The 15% to 20% range is dealing with the traditional end of the market (infectious disease). I think where you are seeing the really exciting growth is with the personalized medicine opportunities. The personalized medicine market will continue to grow with investments from pharma, as well as tests coming from research and tools players. People are looking for easy-to-use platforms that enable testing to happen in hospitals—not just the larger hospitals, but also the medium- and smaller-sized hospitals. The level of investment from pharma companies, in terms of their earlier-stage drugs, has probably been under-called in terms of the excitement we will see from personalized medicine.

IPR: What are your thoughts regarding other opportunities in the field of molecular diagnostics?
White: You have three big buckets: genetics (inclusive of pharmacogenetics), cancer, and infectious diseases. For us, as a multiplex detection company, there are opportunities like respiratory panels that are becoming more popular. I think that people see them as an exciting opportunity. In addition, there are other multiplex infectious disease opportunities. When you look at the genetic testing market, there is more opportunity there, and the cystic fibrosis market continues to grow. We touched on personalized medicine; warfarin is the poster child, but there will be many more good examples. In terms of cancer, that opportunity could dwarf all the others. I think that some of the cancer tests will become mainstream. It is somewhat early stage, and more complicated in that area, but Genomic Health has done an outstanding job in terms of driving that market opportunity.

We are focused on validating content for our platform and tests that will be mainstream in the hospital. We are looking at the cancer market with interest. Developments like the DxS K-RAS test are very exciting and getting a lot of interest. We are trying to stand back. Rather than being the “umpteenth” company to develop a breast cancer test, we are trying to determine if, as this content becomes properly validated, there are ways that we can partner or work with people in that space. Thus, the big areas (as we see it) are:

  • Multiplex detection around infectious diseases. The one- or two-marker tests are doing well now, but opportunity lies with tests like the ResPlex II from Qiagen.
  • We are working in genetics with our cystic fibrosis test.
  • Personalized medicine, and potentially the biggest area is cancer. The key is to attract validated content and work with winners in the field, putting their tests on our platform.

IPR: What do you see in the future for molecular diagnostics?
White: The molecular diagnostics market continues to evolve, and it is gaining momentum and support over time. Sometimes we are pleasantly surprised at the support from large organizations that you would not have anticipated. There is a continual stampede, from the tools companies entering the market and from the pharma companies, which are far more engaged than they were 12 to 18 months ago. A lot of very good organizations are entering this space and looking at how they can improve patient care and deliver validated content to the market. I think the signs are strong and the segment as a whole is holding up very well, even in these economic times, because of the benefits of personalized medicine. I believe the key things we have to focus on and deliver in this market are validated content, further development on the research side, and driving this content to the market by researchers and tools companies.

Further Reading:
The full interview can be found in Molecular Diagnostics: A Dynamic and Rapidly Broadening Market, by Lucy J. Sannes, PhD, MBA. Published by Insight Pharma Reports, January 2009.

Lucy Sannes can be reached at

 This article also appeared in the March-April 2009 issue of Bio-IT World Magazine.
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