Last week, I attended the Harvard Global Health Institute’s 5th Annual Global Infectious Disease Scientific Symposium, entitled “New Diagnostics for Infectious Diseases- From Bench to Bedside” (Agenda), and enjoyed learning about the inventive and creative ideas from the academic bench and the one product from a company that is getting closer to the bedside.
The first speaker was Basil Swanson of the Los Alamos National Laboratory whose technology, “wave guide-based optical detection,” is outside my experience (for details, see Biosensor Team presentation) and seemed too complicated and fragile for practical application. Dr. Swanson’s implementation concept is for a central lab to perform high throughput multiplex biomarker identification on samples sent from around the world via “inexpensive sample transportation” (a US mail truck was pictured). He described a number of challenges (e.g., finding the right ligands and improving sensitivity) and I wish him success.
Samuel Sia of Columbia University spoke next and is well-known around the academic diagnostics community since he is a scientific founder of Claros Diagnostics, based here in Beantown. Investor-funded Claros’s lead product, a doctor’s office-based PSA diagnostic, is in trials for US approval, but its infectious disease products seem to be on the back burner (Tech Review article). So Dr. Sia is moving ahead on a second generation product for diagnosing sexually-transmitted disease (apparently it is clear of any Claros-licensed IP) and noted that the results of its testing in three African countries, funded by the Gates Foundation, will be published soon in Nature Medicine. He also mentioned a cost-effectiveness study by Research Triangle Institute’s Venture Investment Technical Assistance Program (VITA) and Commons Capital that showed this STD test was more cost-effective than immunization. If I have it correct, VITA and Commons Capital got $3 million in Gates Foundation funding but hasn’t published any results, so I, for one, would appreciate reading this report (c.f., my posting of June 17, 2010).
I also wrote a posting about the system that the next speaker, David Alland of the NJ Medical School, had a principal role in developing: XpertÒMTB/RIF, a rapid test for tuberculosis and rifampicin-resistant TB based on a commercial platform of the Cepheid, Inc. (my posting of January 13, 2011, and FIND Press Release). Dr. Alland spoke about the adoption of the test by its intended users, district-level labs in Africa, and provided insight into the challenges of product development, aiming his remarks at the mostly-younger audience eager to apply new technology to global health. i.e., the stuff you don’t learn in grad school. He noted the importance of good engineering design, being creative in finding funding, communicating with a company partner, documentation for regulatory approval, manufacturing QA and retesting, among others. He also noted he needed to find the funding for the trials for gaining US approval and persuade Cepheid to participate, and the studies have recently started.
The next three speakers presented technically sophisticated approaches which, like all new technologies, are very promising but whose application is many years off. Jordi Riu, Universitat Rovira I Virgilia in Tarragona, Spain, is developing multiplexed tests for various pathogens, based on potentiometry, nanomaterials, and aptamers (c.f., Ruis-Ruiz et al. 2011). I was lost in the detail but, from Dr. Riu’s closing slide, Tarragona looks like nice place to visit. Marta Fernandez-Suarez of the Harvard School of Public Health described a TB dx system that uses an NMR detector, shrunk down to the size of a cigarette box, and that is 250x faster than diagnosis based on culturing which takes several days. Still in the works is automating the sample preparation and reducing the size of the desktop reader (Martafs.net). Ming Dao of MIT is starting to work on a malaria diagnostic using “mechano-biological” signals, e.g., changes in shape, flexibility, temperature, or viscosity of cells, and has documented the increase in stiffness and adhesion in infected red blood cells (Bow et al. 2011).
It was fun to hear from Aydogan Ozcan of UCLA who is a rock star of the academic diagnostics world and a recipient of thirteen awards since 2008, including Popular Mechanics Breakthrough Award, National Geographic Emerging Explorer Award, and the Netexplorateur Award (Ozcan faculty page). He is a prolific inventor and an enthusiastic speaker. His theme is “photonics-based telemedicine” in which a cell phone is converted to an ultra-wide field microscope to image the shadows of cells which he has discovered are characteristic of cell type. With further processing, the images can be used to count cells and calculate volumes. One of his devices is a CD4+ white blood cell counter that is under development with a UC Davis lab (TechMagDaily article). While the technology is limited to diagnosing conditions where cells change physically (cancer and some infections) and it is sensitive to sample preparation, it may be the basis of totally new diagnostic approach.
The final speaker was Bill Rodriguez, CEO of Daktari Diagnostics. Thanks to his relentless mastery of the many technical and business aspects of starting up a company, Daktari has raised a few million dollars and has its first product, a portable system for monitoring CD4+ cells in patients being treated for HIV/AIDS, in testing (Daktari). Bill gave three pointers for those in the audience wanting to start a global health diagnostics company. The first was that the starting point for a good product is not the bench but the bedside: knowing thy customer and his/her need will reduce the risk of inventing a solution that is impractical, unusable, or unfundable. The second was that product development is hard and time-consuming, and he had long list of challenges, e.g., sample and reagent handling, power supply, design for manufacture, quality control, and scaling up of manufacture. Finally, Bill spoke about looking for that elusive sustainable business model for global health companies, the one with a saleable/fundable story and a chance at of at least breaking even in five years and providing a (modest) return on investment. For Daktari that model involves a multi-million dollar kick-start via grants and in-kind product development before the company was formed, a reasonable and documented rationale for rolling out multiple products, and a plan to get to market without the time and expense of the USFDA regulatory approval and the reimbursement approval process. Simple: bedside to bench to bedside to business.