In this month’s interview, we talk to William Moffitt, President and Chief Executive Officer of Nanosphere. Mr. Moffitt became president and CEO of Nanosphere in 2004. Moffitt is a 30+ year veteran of the diagnostics and medical device industry, having spent the last 20 years developing novel technologies into products and solutions that have helped shape the industry and generate significant shareholder value. Prior to Nanosphere, he served as President and CEO of i-STAT Corporation, a developer, manufacturer and marketer of diagnostic products that pioneered the point-of-care blood analysis market. Moffitt led i-STAT from an early stage private company through commercialization, an IPO in 1992 and its acquisition by Abbott Laboratories in 2003. Prior to i-STAT, Moffitt held increasingly responsible executive positions from 1973 through 1989 with Baxter Healthcare Corporation, a $7 billion manufacturer and distributor of healthcare products, and American Hospital Supply Corporation, a $3.5 billion diversified manufacturer and distributor of healthcare products, which Baxter acquired in 1985. Mr. Moffitt earned a B.S. in zoology from Duke University.

In our interview, we discuss Nanosphere’s diagnostics technology and the impact of nanotechnology on health care diagnostics. We hope you enjoy the interview. -Steve Waite

SW: Thanks for taking time to speak with us today, Bill. I thought we would begin by discussing the current state of diagnostics technology. What types of advances in diagnostics technology have we seen over the past decade?

WM: We have seen three significant advances in diagnostics in recent years and with them the potential for real, measurable improvements in patient treatment. First, continued discovery of new biomarkers for disease including genetic markers and gene expression ranging from RNA to protein markers. These new biomarker discoveries help advance diagnostics and provide physicians and patients with clinically actionable information that can lead to better outcomes.

Second, although the term personalized medicine created a significant degree of hype and early expectations, there is great progress being made in understanding the mechanisms of action and genetic implications for various therapeutic agents. This will result in a new era for the treatment and prevention of disease using therapies that are more appropriately targeted to an individual. To paraphrase William Osler, a father of modern medicine, “it is more important to know what patient a disease has than what disease a patient has.”

Third, new technologies have emerged that enable complex genetic and protein tests to be performed in virtually any health care setting, thus enabling these new advances to be incorporated into mainstream medicine on a practical and cost effective basis.

SW: What role is nanotechnology playing in advancing diagnostics in health care?

WM: Breakthroughs in nanotechnology have enabled Nanosphere to develop a testing platform – the Verigene System – that can perform both nucleic acid and ultra-sensitive protein assays in a very simple and cost-effective format; and, one that can put molecular diagnostics into any health care setting. Nanotechnology eliminates the complexity and high cost of testing found with other technologies when performing genetic assays for human disease or infectious disease. Moreover, nanotechnology provides a level of sensitivity for protein biomarkers not found in other technologies, which in turn leads to earlier detection of disease. For example, we have in development a test for cardiovascular disease which has already proven to be far more sensitive in detecting heart attacks and acute coronary syndromes. Recent data also suggest that this assay has great value in monitoring patients with chronic heart failure to more appropriately adjust therapy for this life threatening condition. We have also demonstrated the ability to detect recurrent prostate cancer following radical prostatectomy months and years earlier than tests available today. Most oncologist would agree, today the best weapon medicine has to fight cancer is early detection.

SW: Tell us more about your Verigene System and how it is being used today by customers.

WM: The heart of the Verigene System is the nanoparticle probe, which due to its selectivity enables us to format assays on a microarray. The microarray printed on a simple glass slide is incorporated into a unit-use disposable test cartridge that contains the reagents necessary to perform a test. Three very important characteristics arise. First, the microarray gives us the ability to probe for dozens of biological targets in a single test at one time. This makes it possible to perform very complex panels of tests such as an infectious disease assay where any number of bacteria or viruses may be the underlying cause. Second, the unit-use disposable cartridge format makes it economically feasible to run one patient sample at the place and time the physician requests the test. Other technologies rely on batch processing many patient samples at one time in order to lower the cost of any single test. This is not conducive to providing critical patient information when and where it is required. Third, operation of the system is so simple that it can be used in virtually any health care setting. After the user inserts a sample, the Verigene System performs all functions required to provide a test result. The system also incorporates an on-board quality control system to ensure accurate results.

SW: Nanosphere is pioneering the use of gold nanoparticles in diagnostics technology. Why gold?

WM: We functionalize the surface of gold nanoparticles with oligonucleotides or antibodies to create probes for genetic and protein assays. On the nanoscale, gold exhibits the perfect properties for creating high selectivity and sensitivity in biological probes, two attributes critical for the development of assays that must detect the smallest quantities of biological materials. Moreover, the catalytic properties of gold enable rapid amplification schemes, which in our case is the attachment of silver to the particle in the detection phase of the assay. This enlarges the particle and increases its light scattering properties. Gold’s stability at the nanoscale enables us to create reagents with a long shelf life, a property that is important in commercializing products for global distribution.

SW: Who are the primary customers for your nano-enabled diagnostics technology and what kind of feedback are you getting from the market?

WM: Our primary customers are hospital-based clinical laboratories, regional reference laboratories and other professional health care settings. Feedback has been very encouraging as our customers are excited about the ability to perform complex genetic and infectious disease tests when and where they are needed and in a format that is very simple to operate. The Verigene System is enabling testing in locations that could otherwise not perform such diagnostic tests.

SW: What kinds of efficiencies and cost savings are you able to deliver to the market today and how might that evolve in the foreseeable future?

WM: One of the greatest efficiencies delivered to the market is speed to patient diagnosis. Enabling tests to be performed at the point of care and as requested by the physician generates critical diagnostic information when and where it is required. The high cost and complexity of genetic tests has been eliminated through nanotechnology. Nanotechnology has enabled the development of a molecular diagnostics platform that operates in a very simple format thus eliminating the need for highly specialized labor. Moreover, the underlying cost of the consumable test cartridge is very inexpensive, which allows for pricing that is in line with any number of other routine diagnostic tests – tens of dollars as opposed to hundreds or thousands.

SW: We are seeing a tremendous decline in the cost of mapping human genomes. What kind of impact will this have on the diagnostics landscape and how do you see it impacting your company in the future?

WM: Genetic research will continue to advance the discovery of genetic biomarkers for disease and the metabolic pathways of various drugs. Medicine will continue to march toward true personalization. The effect on Nanosphere is very positive as such research programs provide the content for our business. As new genetic markers are discovered, we can incorporate them into our testing platform and rapidly and broadly disseminate the use of these new diagnostic tests.

SW: How do you see the regulatory climate evolving with respect to nanotech in diagnostics?

WM: As with any new science or technology, it will take time for the various regulatory agencies to fully understand the implications of products based on nanotechnology. As nanotechnology replaces the underlying technologies of diagnostic tests, it will be important for the regulatory agencies to develop a better understanding of this new science, which in many instances may eliminate problems associated with other older technologies.

SW: If you look out over the next decade, what kind of impact do you think nanotechnology overall will have on health care?

WM: Nanotechnology will impact both diagnostics and therapeutics. Nanoparticles are powerful constructs for the conveyance of biological substances, whether those substances are to probe for a particular target, as in the case of a diagnostic assay, or block the expression of a particular gene within a cell as a therapeutic agent. The best way to look at what nanotechnology can do is to consider the fact that these particles, which exhibit different functional characteristics on the nanoscale than on the macroscale, operate on the same size scale as the biology. Matching these nanoscale properties to the biology will lead to new discoveries in both diagnostics and therapeutics.

SW: Last question for you today, Bill. What do you think are the major risks for nanotech innovation in diagnostics and health care in general?

WM: Nanotech is having and will continue to have a significant impact on many aspects of medicine and on many established technologies and businesses. One risk is simply the adoption curve and how quickly new technologies are accepted in health care. The process can often be daunting, from clinical trials to the demonstration of not only medical efficacy but also economic sense.

For in vivo applications, manufacturers and developers are going to have to understand the biological and environmental impact and provide data to support safety, but this is really not different from proving the safety of any therapeutic drug or device.

SW: Thanks again for your time, Bill. We wish you and your colleagues at Nanosphere all the best in the future.


Vincent Caprio “Serving the Nanotechnology Community for Over a Decade”
Executive Director
NanoBusiness Commercialization Association