Challenges for Innovation in TB Diagnostics

recent conference at St. John´s Research Institute (SJRI) in Bangalore brought together for the first time over 200 representatives from industry, government, donors, academia, hospitals, civil society and the media to discuss what it takes to innovate in TB diagnostics in India and to move from importation and imitation to innovation.

New diagnostic tests for TB are urgently needed to control the epidemic that continues to affect more than 9 million people every year. Existing tests are slow, insensitive or expensive and require highly specialized facilities which are difficult to provide in resource-poor countries such as India, where TB is rampant.

The diagnostic test currently used by the Indian TB programme (RNTCP) for routine TB cases is sputum smear microscopy; a technique developed over 100 years ago. It requires, despite its apparent simplicity and low cost, experience and skills to read the slides, has poor sensitivity (around 40% of TB cases go undetected) and is unable to diagnose multi-drug resistant forms of TB. By the time patients are identified as sputum smear-positive and initiated on therapy, they may have already infected 15 others in their community. In contrast to the public sector, sputum smears are underused in the vast, unregulated private sector in India which provides care for over half of all TB patients in the country. Instead, TB is often diagnosed with useless serological (antibody) tests that have been discouraged by the WHO. Furthermore, a vast majority of Indian laboratories have virtually no form of accreditation or quality standards.

Undiagnosed and poorly managed TB fuels the epidemic in India and is creating multi-drug resistance. Recognizing these challenges, the Government of India has set the ambitious goal of providing universal access to quality diagnosis and treatment to all TB patients. The Indian TB programme therefore needs new or improved tests to diagnose both drug-sensitive TB and MDR-TB. The conference in Bangalore was aimed at engaging the various stakeholders, especially Indian industry, to stimulate interest and investments in TB innovations.

The conference featured several panel discussions comprised of a mix of different stakeholders that highlighted the challenge of TB diagnostics from its different angles and facets. It seems that the ideal diagnostic test would be a rapid point of care test which is able to diagnose TB at the peripheral level and which has low variable cost. Fixed costs can be expected to decrease due to economies of scale.

The general challenges that industry representatives voiced can be summarized as: Access to sample repositories (for test development and validation) and R&D facilities for TB (e.g. BSL3 laboratories); poor regulatory mechanisms to evaluate new tests and assure quality; lack of clear definition of minimum and optimum target product profiles from either RNTCP, users or donors; unclear definition of market characteristics and size; lack of clarity on what price points to aim for; unclear prequalification process for TB tests by the World Health Organization; general difficulties in accessing knowledge, infrastructure and qualified human resources required for innovation; lack of public awareness for TB and lack of celebrity/philanthropic support from within India; lack of awareness about funding opportunities, weak or non-existent collaboration between RNTCP and industry, between industry and clinicians, industry and academia and general disconnect with the patient or end user; and a generally non-conducive culture for innovation that reduces creative confidence within companies.

The government on the other hand, needs to develop mechanisms to deal with questions such how and when to phase out an older technology and how to embrace and evaluate new technologies for its program. More research and experimentation on a larger scale would be required as currently none of the present players have answers to these questions.

A key challenge is furthermore how the new tools fit into the existing diagnostic ecosystem. Such questions should be considered early on in the design process as they have crucial implications for how the new tool will look like, costs involved, time required, and what effort end users will need to put in. The reason why serological tests are so rampant despite their poor performance is because they fit into the existing ecosystem neatly which incentivizes tests that are neither too expensive nor too cheap and allow all stakeholders involved (e.g. diagnostic manufacturers, distributors, laboratories and doctors) to receive a share of the cost.

The major challenge will likely be in crossing boundaries between different professions and actors engaged with TB diagnostics. There is a general lack of collaboration and coordination, and lack of clarity on what various stakeholders want: What does industry want and need to innovate in TB? What are the diagnostic needs of the RNTCP (target product profiles)? How can governmental agencies (e.g. DBTICMRCSIR) be involved and who should take the lead in supporting TB innovations? Who is the consumer and what does she/he need?

Companies, especially those not working in TB, seem to want “mentorship” or technical advice on TB, and it is not clear who they can approach for issues specific to TB. When and how should companies engage with the RNTCP for advice, possible endorsement or evaluation? As more TB products get developed, it is not clear which agency or organization can conduct head-to-head validation studies to identify the best products for scale-up. More importantly, which agency or organization should take on a convening role to pull together key stakeholders that make up the complete value chain for TB innovations in India? Who can serve as the “honest broker” to bring stakeholders together (and facilitate “match-making”)? How can we increase governmental participation to support TB innovations, especially since more governmental funds are now available for R&D? This justifies conducting further research on these questions and more clearly mapping out different viewpoints, positions, challenges and practices. It also calls for a clear mission statement by a governmental or funding agency on how to move forward and what is required.

The Bangalore conference was clearly a first step to begin a dialogue among the various stakeholders and to support networking among partners. A lot more needs to be done. The conference showed that there is an urgent need to improve and strengthen all sorts of structures supporting innovation in diagnostics (regulation, public-private partnerships, organizational structures to access markets, financing etc.). It also showed that while technology offers solutions it cannot be separated from the socio-cultural context of the TB ecosystem. We cannot focus too narrowly on the development of new tools while neglecting the need to innovate delivery systems, partnerships, funding, regulatory and communication mechanisms. There are no easy technology-fix solutions to TB, because it is as much a social as a biomedical problem. The complicated undertaking of defining what is needed, engaging all stakeholders to collaborate and determining how new technologies can fit into the existing ecosystem of TB control proves this point.

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