3 innovations that could transform TB diagnosis and care

Proteus Discover, a wirelessly observed therapy device comprised of ingestible sensors, a small wearable sensor patch, an application on a mobile device, and a provider portal. Photo by: Proteus Digital Health

GUADALAJARA, Mexico — Ending global tuberculosis will require new diagnostic tools, new ways to support adherence to treatment, new drug regimens, and a vaccine, experts told Devex at the 48th Union World Conference on Lung Health.

The WHO End TB Strategy aims to reduce TB deaths by 95 percent and cut new cases by 90 percent between 2015 and 2035. Some 10.4 million people became infected with TB in 2015, and 1.8 million died, according to the World Health Organization’s 2016 Global Tuberculosis report.

“If we don’t have new tools, then forget it,” Dr. Paula Fujiwara, scientific director of the International Union Against Tuberculosis and Lung Disease, told Devex. “We need new diagnostics, new regimens that work together and a vaccine. To me, if we don’t have these things, then forget it.”

Experts including those gathered in Guadalajara this week are working tirelessly to develop new tools that can transform the TB landscape, including technologies that target diagnosis, treatment, and delivery.

Devex spoke with three TB researchers who presented new findings that they hope will transform efforts to combat the epidemic.

DOT vs WOT

Globally, first-line TB treatment success stands at 83 percent, according to a new report by STOP TB Partnership. The research indicates declining success rates over the past two years.

That downward trajectory is fuelling a sense of urgency to improve patient adherence to Directly Observed Therapy, WHO’s recommended protocol for six to nine months after infection. DOT involves diagnosis by sputum-smear microscopy and medication given under direct observation and supervision by health care workers to ensure drugs are taken at the right time. But this means it is resource intensive and expensive, making its implementation in low-resource settings difficult.

Health care workers may soon be able to remotely monitor their patients for treatment adherence. Wirelessly Observed Therapy is a device developed by Proteus Digital Health that consists of an edible ingestion sensor and an external wearable patch, which, when paired with a mobile device, can detect and record when patients take their medicine.

When patients take their pills, the ingestion event is recorded and uploaded to a secure internet server, so health care workers can remotely confirm that pills were taken. The ingestions can be followed in real time and there’s no limit to the number of patients health care workers can monitor.

In addition to allowing remote monitoring, digitizing could improve accuracy, preventing unnecessary changes in therapy such as stopping certain drugs or switching to other ones.  

Researchers think WOT has the potential to replace DOT.

“The implications for the developing world are really enormous … because they lack adequate public health infrastructure and medical personnel,” Sara Browne, professor of clinical medicine at the University of California who has been involved in a study analyzing the effectiveness and accuracy of WOT, told Devex.

DOT is “really difficult to run. We’ve got new drugs, but for successful treatment, we need treatment monitoring and adherence support. This is putting us in a whole new world.”

Browne is now working with experts to analyze the global cost of rolling out such a device and is hoping to begin larger clinical trials in South Africa soon.  

Oral swabs

The standard diagnostic test for TB involves patients coughing up sputum, which is difficult to collect, analyze, and handle. It’s also often unreliable.

Researchers have now found that oral swabbing — that is, taking a sample from inside the mouth with a glorified Q-tip — is a safe and easy alternative to sputum collection for TB diagnosis.

“We never set out to have this be a total replacement for sputum collection, but now we think it’s possible. We think it will replace sputum,” said Gerard Cangelosi, adjunct professor of global health at the University of Washington, who has been investigating the use of oral swabs for TB diagnosis.

Cangelosi believes the oral swab could have huge implications for high-burden TB countries such as India and China, where there’s a push for active case finding.

“We could be going out to communities and finding TB cases before people even know they have it. It could reduce the transmission and burden of TB,” he said. “If you have a classroom, a workplace, or a family exposed to TB, you can’t go and collect sputum from them, but you can collect samples using oral swabs. Imagine that you can use oral swabs and sample an entire classroom of children in a few minutes.”

The oral swab has only been tested on a small number of patients but is currently being trialled in about 150 patients in South Africa.

While it will remove the need for using sputum, the swab will still need to be analyzed using either a GeneXpert machine or PCR assay.

Rapid blood test

The lack of a reliable and efficient blood diagnostic tool is one of the major obstacles reaching the global TB goals. A rapid, non-sputum based test that can rapidly screen for active TB is considered to be one of the field’s most pressing needs.

A new blood prototype test, which takes less than 15 minutes to run, is showing promising results.

Researchers from France have developed a blood test that doesn’t require power or health care worker training, which can be used outside of health care facilities anywhere in the world. The test only needs a few drops of blood, placed on the device. Results appear within 15 minutes.

“Everybody could use the test, even people without medical training, and maybe even the patient as well,” said Pierre-Alain Rubbo, president of Omunis, a company that develops new blood diagnostic tools for infectious diseases and which developed this TB test.

“It will be as easy as a pregnancy test, but with blood samples. It has the potential to become the gold-standard for large-scale tuberculosis screening, as similar tests are the gold standards for other diseases like HIV or hepatitis.”

Rubbo said the next step was for the prototype test to be evaluated in larger numbers of samples, including patients who are also HIV-positive. He said his team is currently evaluating the test using samples from the Foundation for Innovative New Diagnostics.

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About the author

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    Sophie Cousins

    Sophie Cousins a Devex Contributor based in South Asia. She is a health journalist focused on women and girls. She was previously based between Lebanon and Iraq, focusing on refugee health and conflict. She writes for international medical journals, including The Lancet, and for international news websites such as the Guardian.