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Apr 1, 2009 (Vol. 29, No. 7)

MDx Will Drive Personalized Medicine

Prediction Expected to Hold Only if the Novel Suite of Technologies Can Save Healthcare $$$

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    The Erenna Immunoassay System utilizes a modified microparticle-based sandwich immunoassay followed by single-molecule counting technology to enable early disease detection, according to Singulex.

    Global trends in molecular diagnostics was a key topic of discussion for an expert business panel at the recent “CHI Molecular Medicine Tri-Conference” in San Francisco.

    The panel predicted that some of the approximately $50 billion of President Obama’s stimulus package will be allocated to electronic medical record (EMR) opportunities and will directly impact the diagnostics market. By expanding access to a patient’s records and making them portable, EMRs will foster the use of point-of-care diagnostic tests.

    Harry Glorikian, a partner at Scientia Advisors, spoke of the growing recognition that diagnostics will be a significant enabler of reduced healthcare costs. He identified several major global drivers of an expanding market for in vitro and molecular diagnostics: an aging population; an increase in chronic diseases (as therapeutic regimens improve); the availability of high-value diagnostics; and growth in decentralized healthcare (e.g., China plans to establish about 60,000 healthcare clinics by 2012).

    Glorikian described increasing scientific innovation in Eastern countries, where products can be made for a fraction of the cost in the U.S., with similar quality, and projected a shift in the flow of products from Asia to the West in the near future.

    Diagnostics offers the potential for shorter timelines to market and profitability, noted a venture capital panel during a discussion entitled, “How Is Personalized Medicine Moving Forward?”

    Although, historically, diagnostics were less heavily regulated than drugs, that equation appears to be changing for molecular diagnostics, at least within the U.S. FDA. The panelists advised that when a company develops a companion diagnostic it has to consider whether the product can reap a profit, but it also has to assess the cost/benefit for all concerned, including the patients (Will insurance cover it?), the physicians (Will they be reimbursed?), and the healthcare system (Will the test reduce the overall cost of care by enabling the use of targeted, more effective treatments or identifying early on therapies not likely to be effective?).

  • New Twists in Point-of-Care

    To bring a new biomarker-based diagnostic test to market takes an estimated three years and $45–50 million to complete outcome studies. From first investment to revenue production, this estimate rises to $70–100 million.

    A medical expert panel that discussed the “Future of Point-of-Care” pointed out  that with the emergence of “quick clinics” in grocery stores and shopping centers, for example, it is clear that people are willing to pay out-of-pocket to seek advice for managing their healthcare outside traditional treatment settings.

    Quantitative diagnostic tests are facilitating a shift in trust, from relying on a physician to deliver and interpret test results, to a point-of-care model, noted the panelists. This trend will not likely impact test volumes at central laboratories, which are enjoying increasing revenues at a rate of about 5% per year, largely due to the aging of the population.

    Technology that enables the development of robust, easy-to-use test kits will drive growth in the home diagnostic testing market, as patients will begin to manage their own diagnoses and treatments, bypassing the physician’s office.

    What did the participants identify as the most significant current barrier to the development of point-of-care diagnostic tests? The issue of reimbursement, which will largely determine physician adoption. In-office testing would save physicians time and enable a test-and-treat model of care in a single visit. These products will give physicians faster and better answers, but they must be affordable.


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