Cepheid - The key to fast diagnoses

Can you give us a brief run-down of your background in TB?

Dr Davide Manissero: As a medical doctor, I trained in paediatrics and tropical medicine and got involved early on in childhood TB management and control. I worked on TB for World Health Organisation in Indonesia and at the European Centre for Disease Control in Stockholm, where I coordinated the TB programme for five years. For the past eight years, I have been working on TB drug and diagnostic development. Currently, I work on antibiotic development as senior director for infectious disease at Shionogi and I am engaged as honorary senior lecturer at University College London's Institute for Global Health.

From your point of view, what are the biggest challenges in TB and its diagnosis at the moment?

I like to summarise them with two words: prevention and prevention. Firstly, prevention of progress from TB infection to active TB - commonly referred to as TB preventive treatment - for which truly predictive diagnostics and a more patient-friendly preventive drug regimen are urgently needed. Secondly, and of no lesser importance, is the prevention of TB transmission. While existing regimens for drug-sensitive and multidrug resistant TB (MDR-TB) are sufficiently effective, their introduction to patients is often delayed. This is the biggest impediment to progress towards TB elimination, and the key driver of transmission and persistent infections in the community.

While existing regimens for drug-sensitive and multidrug resistant TB (MDR-TB) are sufficiently effective, their introduction to patients is often delayed.

What changes have you noticed in European TB management over the past few years?

I have seen two over the past decade and I believe the jury is still out on their potential impact. These are changes that originate from the need to address the two challenges I have just described. The revamping of TB prevention as a key pillar of programmatic TB control is one of them; it has been triggered by policy stimuli rather than by new tools. The introduction of fast diagnostics has, on the other hand, been secondary to the development of new tools that have forced policy adaptation, and are inducing a decentralisation of TB control that should benefit more patients and ultimately impact the epidemic itself.

Reducing diagnostic delay is a major topic in active case finding. What are the most important factors in bringing a fast diagnostic test to patients?

The ability to adapt the health system to fast diagnosis is key to the success of fast-diagnostic platforms. New diagnostics can do very little if the newly gained speed is not matched by making drugs readily available at the point of care, retraining relevant healthcare staff and preparing the community for these changes.

What is your experience with TB fast diagnostics and the GeneXpert System specifically?

While working on a novel MDR-TB drug, we conceived a project aimed at assessing the feasibility of MDR-TB decentralisation and creating conditions for an outpatient MDR-TB approach in certain areas of Moldova, a high MDR-TB-burdened country. The implementation of GeneXpert at peripheral healthcare facilities, availability of second-line drugs outside of referral hospitals, adaptation of local decision-making flows, and a network of community support for the patients and their families were key to the project's success. It was rewarding to see how a fast rifampicin-resistance diagnosis, embedded in a highly supportive health system, would open the door to revolutionising the MDR-TB treatment towards a less disruptive diagnosis for patients and their families.

What benefits does Cepheid's decentralised testing solution have for clinicians and patients?

Decentralised testing intended as a move towards bedside or health centre diagnostics does not semantically do justice to its importance from a human and social perspective. I mentioned the importance of fast diagnostics from a control point of view, however, we should not forget that these fast tools are the gateway to reducing time to effective therapy, and thus dramatically increase the chances of survival and reducing the severity of disease in patients.

The views expressed in this article are those of the interviewee and not those of his employer or affiliation.

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