Target product profile for next-generation TB drug-susceptibility testing at peripheral sites

 The updated profile provides direction for the development of rapid DST that can be used at the peripheral level of the healthcare system (the rapid DST test). As with other TPPs, the updated targets for next-generation DST intertwine performance characteristics and aspects related to the sustainability of envisioned technologies. This TPP is aimed at test developers and manufacturers, research institutions, product development partnerships, among other organisations. It is set to steer the research and development arena and encourage the TB community to address diagnostic gaps in a rapidly changing landscape and to enable the development of next-generation drug-susceptibility tests that can be deployed to lower levels of the health system.

Early diagnosis of TB and identification of drug resistance are a key component of the End TB Strategy’s Pillar 1 – on integrated, patient-centred care & prevention, and is vital to reach the 40 million target set in the political declaration of the UN High-Level Meeting on TB.

“Ensuring that all people with TB have access to universal drug-susceptibility testing is a critical element in our fight to end TB,” said Dr Tereza Kasaeva, Director of WHO’s Global TB Programme. “While the landscape of TB diagnostics has evolved dramatically in recent decades, one major obstacle continues to be access to better tools, that are near to the patient, to rapidly diagnose, guide treatment and interrupt transmission of  M. tuberculosis. The attributes presented in this TPP can help bring us a step closer to tackle current and emerging challenges, in particular, for the rapid detection of resistance to new TB drugs”.

This TPP was developed with the support of the New Diagnostics Working Group, and, in consultation with a wide range of stakeholders including, national TB programmes, civil society, partners and regulatory authorities. In moving forward, WHO will continue to monitor the development of new tools and engage with end-users, patient representatives and test developers to revising this and other TPPs to keep pace with the needs of the TB community as well as developments in TB treatment and diagnosis.