In the in vitro diagnostics industry, the “box” is the instrument that measures the reaction between a reagent and a disease-relevant analyte (biomarker) to provide information about the disease or condition of interest. In the resource-rich countries, samples are obtained from patients by technicians, sent to a central lab for processing, and the results returned to the supervising physician. In our hospital- and doctor-centric system, there is less need, and therefore less commercial interest, in point-of-care (POC) diagnostics in which a sample processed and the results read shortly after being taken. That being said, the 2007 world market for POC tests was $11 billion (POC Market) out of a total in vitro diagnostics market of $38 billion (IVD Market), and the interest in companies in developing more POC diagnostics is growing, in part due to growing sales in OTC glucose monitoring and pregnancy testing, the general pressure to control healthcare costs, and the potential of markets in emerging economies and in the public health sector.
The role of diagnostics in global health is addressed in a recent publication by BIO Ventures in Global Health: The Diagnostics Innovation Map. Medical Diagnostics for the Unmet Needs of the Developing World (BVGH Report). The report is a comprehensive review of in vitro diagnostics and points out that early diagnosis of infectious disease results in early treatment with the right drugs and reduction of the evolution of drug-resistant strains, and therefore has the potential to save millions of lives and avoid unneeded treatment of hundreds of millions (see the table on page 12 and Appendix II). The report also summarizes the specifications for diagnostics in the low-resource settings, the technology behind current and emerging diagnostic methods, and the need for greater collaboration between the non- and for-profit entities in bringing the needed diagnostics into commerce and points out the innovations to address the unmet need. Over all, a good read (which I haven’t completed yet). Another useful report is by the UK’s Academy of Medical Sciences (Global Health Diagnostics); other resources and publications may be found at the Foundation for Innovative New Diagnostics (FIND Resources).
Under the big tent of the annual BIO (Biotechnology Industry Organization) meeting last week (BIO 2010), diagnostics was in a small ring and diagnostics for global health was at the edge of that ring. I noted two global health-related sessions and attended one: “Solving Challenges in Global Health Diagnostics, Creating Opportunities in Global Markets” (the other was “Devices and Predictive Diagnostics,” chaired by Charles Cooney, Professor of Chemical and Biochemical Engineering, Massachusetts Institute of Technology). The “Challenges” session was chaired by David Anderson (Anderson Bio), Deputy Director of the Burnet Institute which is Australia’s leading research and development institute for public health (Burnet). I gleaned the following insights (in order of the presentations):
Gloria Young, Vice President, Global HIV/AIDS Initiatives, BD Biosciences (Young bio) noted that:
-while there is funding from donors to acquire diagnostics for HIV/AIDS, the real need is in funding technicians and support personnel to process the tests (only 40 such people in all of east/south Africa); and
-BD Biosciences is willing to be a distribute diagnostics for global health and to acquire companies with innovative technology.
Paul Lambotte, Chief Scientific Advisor, Axxin Ltd (Lambotte bio) said that:
-the “form factors” for diagnostics in high/low resource settings are the same (need to be connectable, reliable, rugged, cheap) and therefore diagnostics companies should be planning to market their products for global health uses; and
-one challenge is that, while companies like can design and make POC readers, they need other companies to make the tests that utilize the reader, which adds complexity to the business model.
Matt Steele, Program Officer, PATH (Steele bio) pointed out that:
-one of the services of PATH’s Center for Point-of-Care Diagnostics for Global Health is to help companies sell their products to the major procurers [although he did not specify who or how];
-other services include facilitating regulatory approval and advocacy for adoption of new products [who/how?];
-the Center has funded [and will fund, but internally only?] small-scale technology development projects (about $30K worth), laboratory evaluation (about $50-150K), and field testing (about $150K) [how does one apply?]; and
-his experience is that innovation is the easy part, the hard part is implementation and support, and donors are not interested in funding the latter.
Suzanne Crowe, Head, Pathogenesis and Clinical Research Program, Burnet Institute (Crowe bio) provided an example of the Institute’s role in developing a diagnostic for hepatitis E:
-seven years ago their researchers had designed a ELISA assay prototype, but, for some reason, could not reach an agreement with the most likely commercial partner, MP Biomedical, which held a key patent; but
– eventually did a deal and the company completed manufacturing development in 6 months and now sells a HEV diagnostic (MPBio HEV Kit) [but apparently only outside the US, suggesting that clinical trials were not done].
Kara Palamountain, Research Associate Professor at the Kellogg School of Management, and Executive Director of the Global Health Initiative, Northwestern University (Palamountain bio) spoke about:
-a program that uses graduate students “to develop that IP [donated by companies] and take the products to market“ (GHI Opportunity);
-an example in which MBA students had done a market study for new diagnostic test in Zambia; and
-use of the program by companies to do similar projects [how?]. [I would have rather she spoke about how the Initiative’s sister Northwestern program, the Center for Innovation in Global Health Technologies, used its $5 million Gates grant over the past three plus years to develop and launch new diagnostics, if any (Gates Grant PR)].
For me, as an adviser to a start up company looking for funding for the development of a novel POC technology, the chair did a good job in bringing together representatives of academia, not-for-, and for-profits who had emphasized the role of collaborations in solving the challenges. I plan to follow up with several, but overall I would have appreciated more ideas on how to create the market opportunities which are needed to pull the investment needed for innovation, as advertised. The BVGH report has a chapter on “Incentives for Diagnostics Innovation,” and it mentions the current incentives for therapeutic innovation (advance market commitments, priority review vouchers), describes the factors to be considered in designing incentives, but makes no specific recommendations. Without a whole lot of research, I’d propose the following are worth exploring:
-an advanced market commitment by public health procurement agencies like the USAID in which the agency would set the product specifications and front some portion of the contract to fund development;
-similarly the diagnostic product development programs (the public- and private-funded non-profits, e.g., FIND and PATH) could award contracts through a competitive process for product development, rather than funding academic groups for research; and
-more SBIR money could be made available to diagnostics companies through agencies like the NIAID.
Other ideas anyone?