Infection by the TB infectious agent, Mycobacterium tuberculosis can exist within the human body as a contained latent infection, active disease, or be eradicated by the host immunological response. TB diagnostics are required to categorize a patient into one of these categories. However, case detection remains difficult today due to inaccurate diagnostic methods and confounding factors such as HIV infection, immunosuppressive therapies, anti-tuberculosis treatments, drug-resistant TB bacteria strains and poorly understood other factors. Modern-day TB diagnostic tools in developed countries are neither appropriate nor affordable for resource-poor environments. National TB programs in disease-endemic countries still rely on older and inaccurate methods for confirming TB in patients. Without correct diagnosis of a patient’s condition, there is lower probability that appropriate medical treatment will be provided and effect a cure of the disease.
To reach the Stop TB Partnership Goal of TB no longer being a public disease burden by 2050, new and improved point-of-care diagnostics need to be developed. Two entrepreneurial efforts, one from a high-income country (USA) and one from an emerging economy (India) are profiled here.
Cepheid is the publicly-listed firm and the maker of the GeneXpert system. GeneXpert allows testing for both drug-sensitive and drug-resistant strains of M. tuberculosis with real-time PCR and front-end sample processing in one self-contained closed cartridge; allowing DNA testing to be conducted in robust environments. Cepheid was founded in California in 1996 with an initial concentration on micro-electromechanical systems (MEMS) technology. After MEMS failed to produce the desired results the company refocused its efforts on a more robust approach using more traditional microfluidics. Over the years, it has evolved from an industrial and biothreat focused firm to a clinical diagnostic company where medical applications of its technology makes up the majority of sales. The World Health Organization approved the Cepheid GeneXpert TB test in December 2010. An open innovation business model that involved an academic public/private partnership with the University of Medicine and Dentistry of New Jersey to assist with assay development; the Foundation for Innovative New Diagnostics (FIND) to enable product development and clinical trial support and the National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Health (NIH) to extend GeneXpert capabilities.
Another type of open innovation is occurring at the Institute of Science Bangalore Entrepreneurship Centre, India where BIGTEC Laboratories is incubated. It holds academic collaborations with seven public Indian institutes of science and technology to complement its knowledge base. Kickstarted by a soft loan from the Indian government Council of Scientific and Industrial Research (CSIR) BIGTEC was founded in 2000 to make point-of-care diagnostics using MEMS technology. It is working on late stage validation for a TB-specific test.
It is interesting to compare and contrast these two private sector efforts. Both firms are applying their technology base to a portfolio of disease areas, one of which is to address the unmet need in TB. The innovation ecosystems for the two firms are very different and the sources of resource funding also vary. Cepheid was venture-backed when it first started, followed by nominal support from government grants for its biothreat work and primarily funded by an IPO in 2000. Its initial TB portfolio work also obtained funding from the FIND collaboration (funded by the Bill & Melinda Gates Foundation) along with NIAID/NIH grants. BIGTEC’s first major backing came from the government of India and in April 2011, evolved its business model and entered into a joint venture with the Tulip Group from Goa, India to create Molbio Diagnostics, Goa to house their Truelab microPCR analyzer technology, which includes its TB work. The joint venture allows BIGTEC to separate its TB development risk from the rest of its portfolio. It also allows BIGTEC to focus on product R&D while leveraging the marketing acumen and infrastructure of the Tulip Group to address unmet medical needs in resource-limited settings.
All innovators in the TB space recognize that employing an accurate, affordable and timely point-of-care diagnostic is essential in combating this infectious disease. It is also clear this objective can rarely be achieved alone. These two case studies illustrate different applications of open innovation in their business models to progress R&D innovations in TB diagnostics.
 Wallis, R., Pai, M., Menzies, D., Doherty, T., Walzl, G., Perkins, M., et al. (2010). Biomarkers and diagnostics for tuberculosis: progress, needs, and translation into practice. The Lancet, 375(9729), 1920-1937.