Target product profile for next-generation TB drug-susceptibility testing at peripheral sites
10 August 2021 | Geneva - The World Health Organization (WHO) is launching its updated target product profile (TPP) for next-generation drug-susceptibility (DST) testing for M. tuberculosis at peripheral centres.
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.
Source:
World Health Organization
