WHO hails Quadram and Oxford Nanopore in global fight against TB

The test under development is one of three sequencing-based tests for TB supported by the WHO in a significant step in the global fight against infectious disease.

The WHO says the solution meets the class-based performance criteria to detect drug resistance after TB diagnosis, to guide clinical decision-making for drug-resistant TB treatment.

This is among the first sequencing-based tests to be supported by the WHO in the field of TB – and a significant milestone in the fight against one of the most persistent threats in public health globally.

Drug-resistance remains a major barrier in global efforts to curb the spread of TB, which was the world’s second leading infectious killer after COVID-19 in 2021, according to WHO.

TB remains one of the deadliest diseases in the world, with an estimated 10 million reported new cases in 2020, 1.5 million deaths and three million undiagnosed patients.

The lack of rapid, accessible and information-rich tests for DR-TB has stymied progress in combating the disease by making it harder to successfully control and treat. Major healthcare organisations and non-profit organisations have identified sequencing-based drug resistance testing as a priority.

In 2019, the Foundation for Innovative New Diagnostics (FIND), a global non-profit, launched the Seq&Treat programme, funded by Unitaid and in collaboration with WHO, to investigate whether DR-TB detection could be improved by introducing and accelerating the uptake of next-generation sequencing solutions in clinical settings.

The FIND study investigated Oxford Nanopore’s rapid, end-to-end sequencing test in development, which identifies mutations associated with drug-resistance across the TB genome in DNA extracted from sputum within as little as five hours.

The test, which allows flexible sample batching and can be performed rapidly, includes worldwide exclusively licensed technology from Quadram Institute Bioscience.

The evaluation was carried out in two phases, culminating in the successful completion of Phase II in May that followed performance evaluations from clinical samples in India, South Africa and Georgia.

Success in this final stage of the Seq&Treat study and support from the WHO confirms that the Oxford Nanopore sequencing solution meets the diagnostic performance criteria outlined in the NGS Target Product Profile established by FIND/WHO for clinical diagnosis of drug resistant TB.

The Oxford Nanopore sequencing test is in active development on a pathway to pursuing regulatory approval. In April, Oxford Nanopore announced a strategic partnership with bioMérieux, a world leader in the field of in vitro diagnostics, to develop innovative infectious disease diagnostics. This includes collaboration on market access and deployment of the TB Drug Resistance assay.

Once complete (and consistent with WHO guidelines and applicable law) this test is anticipated to offer countries in which TB remains a persistent public health threat a faster, accessible option to detect drug resistance in patients.

Rapid and comprehensive detection of resistance directly from patient samples is required to initiate appropriate therapy, thereby improving patient outcomes and reducing the spread of DR-TB.

Gordon Sanghera, CEO Oxford Nanopore Technologies, said: “For the first time, a sequencing-based test has been supported by the WHO in the field of TB.

“This is a watershed moment in the fight against a serious threat to public health and, over time, could stop the spread of drug-resistant TB through faster, more accessible diagnostics. We’re excited to receive the WHO’s support and look forward to working with our partners to bring this test to market.”

Professor Ian Charles, Director of Quadram Institute Bioscience, added: “The growth of drug resistant TB is a major global public health concern and innovative and accurate solutions that deliver benefits at the point of care are needed urgently.

“It’s very satisfying to see the results of these Phase II trials and to see how licensed technology from research undertaken at the Quadram Institute has supported the development of this new diagnostic tool to combat TB. We look forward to seeing its deployment in those areas of the world where it will deliver real life-saving impact.”

• Photograph: Professor Justin O’Grady from Oxford Nanopore Technologies with next-generation sequencing equipment in the Quadram Institute laboratories. Image copyright of the Quadram Institute.