A couple weeks ago I enjoyed meeting with a relatively new special interest group in the Boston area, Diagnostics Innovations for Global Health (DIGH). Composed of scientists, engineers, and physicians in the early stages of their careers, the group meets regularly to learn from each other and outside speakers about the practicalities of developing and commercializing new diagnostics for global health. There were good questions in the Q and A after my wide-ranging (rambling) talk, one of which was on the challenge faced by all technological innovators: how to fund moving an invention out of the lab and into commerce? We discussed a few of possibilities (Gates Explorations grants, prize money from business plan competitions), but I was remiss in not pointing out that it helps to have a solid starting point: a well-described need for a specific diagnostic, i.e., one that may yield a measurable improvement in health.
Fortunately, and thanks to the B and M Gates Foundation, Nature Publications, and the RAND Corp., a forum of experts was organized to identify and quantify diagnostic needs in global health in 2004, and the forum’s findings were published in a series of papers in 2006 (Improved Dx for the Developing World). The papers are pretty in unique in that each working group was charged with, and delivered, an analysis not only of the technical requirements of the needed diagnostic (the target population, sensitivity, targets) but also of the potential improved health effect if the diagnostic were used to guide currently-available treatments. The latter is especially useful for the developer of a new technology for creating a business case for the new product and in quantifying an albeit speculative return-on-investment for a funder/investor. Each of the papers used similar modeling and analysis techniques that were explained and discussed in the lead paper (Girosi et al. 2006). The diseases covered were those causing the greatest burden on health globally: acute lower respiratory infection in children; HIV/AIDS in infants; stunting due to diarrheal infection among children; childhood malaria; tuberculosis; and sexually-transmitted infections. Since the studies were done six years ago, I imagine some data may need to be reconfigured to account for incremental improvement in treatments, but the forum’s work is a solid basis for a start-up or growth business plan for a global health diagnostic company.
Another resource for data useful for developing a global diagnostic business case is a report completed in 2008 by the IKP Centre for Technologies in Public Health (ICTPH), an Indian non-profit consulting firm for “providing accessible and affordable health care solutions.” While not nearly as comprehensive as the 2006 forum papers, the report summarizes market data for point-of-care (POC) diagnostics for diabetes, maternal and child health, tuberculosis, malaria, and diarrheal diseases primarily for India and for the world in general and also notes some current and emerging POC tests (Ben-Hiam 2008). I also recommend the ICTPH’s blog for an in-country viewpoint of India’s health care system, useful to anyone developing diagnostics for India (ICTPH Blog).
More recently in 2010, BIO Ventures for Global Health published the Diagnostics Innovation Map (BVGH Dx) in line with its mission of encouraging the application of developed world science and technology to global health problems. Although weak on providing a map, the report is a nice summary of the need and new technologies and has a good discussion of the incentives possible for diagnostic development, including a favorite of mine, having donors offer purchase commitments to companies meeting certain product specifications, ala the advanced market commitments offered by GAVI for vaccines (well, two so far). The report offers its most specific guidance in an appendix list of fourteen examples of needed biomarkers and diagnostics. Finally, the Foundation for Innovative New Diagnostics (FIND) has several publications specific to:
- Point-of care diagnostics in general (POCs);
- Tuberculosis (Path to Better Dx, Lab Dx, and TB Dx Demand and Market); and
- Malaria (Field Trials for RTDs).
An additional way to identify global health diagnostics needs is to look at what the few funding sources for new diagnostics have identified as needs. And, if your timing is right, you are good at grant writing skills, and, for the Small Business Innovation Research (SBIR) grants, have already started your start-up, you can apply, keeping in mind competition for grants is stiff. As I mentioned above, the Gates Foundation Grand Challenges Exploration program has offered a few grants for diagnostics development (Gates Explorations), most recently for the neglected diseases of lymphatic filariasis, onchocerciasis (river blindness), and soil-transmitted helminthic infection (Round 10). Another funding source is the NIH SBIR program. Reading though the most recent solicitation (PHS 2013-1), I noted that the Centers for Disease Control and Prevention’s Center for Global Health has three solicitations in diagnostics: Diagnostic Needs for Neglected Tropical Diseases (NTD) Programs (p. 104); Rapid Screening Tests to Prevent Congenital Infections and Ensure Blood Safety (p. 105); and Development of Diagnostic Tests for Strongyloidiasis and Schistosomiasis (p. 105). The National Center for Emerging Zoonotic and Infectious Diseases is looking for help with: Development of Nanoparticle Dengue Diagnostic Tests (p. 109) and Development of Tests in a Standardized Kit Format for Diagnosis of Arboviral Infections in Resource Limited, Primary Health Care Setting (p. 110). And the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention has one solicitation for the Development of a Portable Multiplex Assay for Determination of Recent HIV-1 Infection (p. 112).
I hope this is helpful background for anyone writing a business plan or polishing a pitch.