Last year I wrote a post about the Harvard Global Health Institute’s Global Infectious Disease Symposium on new diagnostics and noted that it was fun to hear from Aydogan Ozcan, a professor of electrical engineering at UCLA (Ozcan faculty page). He is an enthusiastic speaker and spoke on his work on cellphone-based diagnostic devices, aka “photonics-based telemedicine.” One of his devices now under development with a UC Davis lab is a CD4+ white blood cell counter in which a phone is converted to an ultra-wide field microscope to image the shadows of cells which, with further processing, can be used to count cells and calculate volumes (TechMagDaily article). While clearly there is a need for cheaper CD4+ cell counters for monitoring HIV treatment (e.g., Daktari Diagnostics’ first product), I think the shadow-imaging technology’s use may be limited to diagnosing conditions where cells change physically (cancer and some infections) and may be overly sensitive to sample preparation, so may not be the basis for other global health diagnostic products.
An Ozcan device that may have better utility and really make a difference in health care in developing countries was reported recently. It is an attachment for phones that can read the output of rapid diagnostic test (RDT) strips, yielding a “digital universal reader for all RDTs, without manual decision-making” as Prof. Ozcan was quoted (R&D magazine article). RDTs are widely available for many diseases (more than 7000 are listed on Alibaba RDT) and, being inexpensive and low-tech, are appropriate for under-resourced settings (see USAID’s and PATH’s RDT Info). I was not able to figure out how universal the Ozcan device is (e.g., does it read outputs of the four main RDT types, lateral-flow, flow-through, solid-phase, and agglutination) since access to the related publication requires a subscription (Mundnyall et al. 2012). However, the authors note in the abstract that they tested the device with RDTs for malaria, tuberculosis, and HIV so it may be multi-platform. Possibly the attachment will be useful in point-of-care diagnosis by enabling more accurate and reliable reading which is influenced by lighting conditions, rate of color/image development, and reader/interpreter experience. Depending on the sophistication of the phone, the device may also enable storage of images and related data and their transmission. As the authors state: “Providing real-time spatio-temporal statistics for the prevalence of various infectious diseases, this smart RDT reader platform running on cellphones might assist health-care professionals and policy makers to track emerging epidemics worldwide and help epidemic preparedness.”
All that being said, what is being or has been done to turn this invention into a product? Not much as far a I can tell. The likely assignee, the Regents of the University of California, has not filed a patent application (Ozcan Patents), and, if the plan is to license the know-how because the technology is not patent-eligible due to prior disclosure or art, UCLA has not listed it as available for licensing (UCLA Commercialization Opportunities). It is possible that UCLA and Prof. Ozcan (and maybe Partners Healthcare since he was a researcher at Man’s Greatest Hospital, MGH, here in Boston) are negotiating with investors for a start-up company. After all, a key to attracting cash these days is to have a founder with lots of media power (Ozcan Lab in the News). Were I responsible for helping with the commercialization, I would not look for an exclusive licensee among the big diagnostics companies, most of which are not interested in RDTs, or the many RDT companies, for which the features added to their products would not likely increase sales (RDT is a commodity business). I think the best route would be to start a virtual company that would license to companies developing RDTs or other point-of-care diagnostics based on propriety technology and therefore adding value to their products and justifying adoption by their most likely customers, the public heath agencies. Two companies that come to mind are Diagnostics for All (DFA) which is (still) working on paper-based, ultra-cheap RDTs and the Institute of Bioengineering Technologies, Inc. (IBET) which is working on a field test for iodine deficiency.
Of course, the rub is funding such a start-up. In my post, “Thinking Out of the Box” 6/23/11, I recommended three ways that the government- and/or donor-backed organizations could help global health diagnostics companies:
- 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., Foundation for Innovative New Diagnostics, FIND and PATH, PATH Dx) 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.
Anyone want to go in with me on a start-up?