Economic challenges associated with tuberculosis diagnostic development

Abstract

Tuberculosis remains a global health crisis in part due to underdiagnosis. Technological innovations are needed to improve diagnostic test accuracy and reduce the reliance on expensive laboratory infrastructure. However, there are significant economic challenges impeding the development and implementation of new diagnostics. The aim of this piece is to examine the current state of TB diagnostics, outline the unmet needs for new tests, and detail the economic challenges associated with development of new tests from the perspective of developers, policy makers and implementers.

Keywords::

• diagnostic development
• diagnostics
• economic evaluation
• tuberculosis
• tuberculosis control policy

Acknowledgements

Thanks to Susan Doman for critical review of this manuscript.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Tuberculosis (TB) remains a global health crisis. Only two-thirds of those who develop TB each year are currently detected.

• Current TB diagnostic tools have suboptimal sensitivity and specificity. The reference standard test, mycobacterial culture, is costly, slow and unavailable in many settings due to limited laboratory capacity. Technological innovations are now needed to improve diagnostic test accuracy and reduce the reliance on expensive laboratory infrastructure.

• New TB diagnostic tests should provide rapid test results in an easy to use format, have good diagnostic accuracy, have easy and simple specimen collection and represent a low biosafety risk during operation.

• TB disease is heterogeneous and complex, posing challenges for diagnostic test development.

• Emerging tests may have ‘niche’ markets targeting specific TB disease manifestations or target populations.

• Challenges from the test developer’s perspective include: the need for well-defined target product profiles; the push–pull between ‘one size fits all’ and a condition specific test; costly development considerations including extensive clinical trials and the concentration of disease within low-income countries.

• Challenges from the policy perspective include: difficulty in assessing patient impact of new diagnostic tools; lack of data on performance and impact of test implementation within existing diagnostic algorithms; cost–effectiveness studies may be highly context dependent and may not translate into an ‘affordable’ test.

• Challenges from the programmatic perspective include: multiple technologies emerging within a short space of time; technologies that are first to market have significant advantage over ‘fast followers’ but may not have superior target product profiles; policy while an adequate number of high-quality studies are completed; guidance for diagnostic studies often lacks crucial practical programmatic implementation considerations.