A five-inch, battery-operated black box could be the future of tuberculosis diagnosis. The device, developed this year by a team of Texas doctors, can spot tiny amounts of TB bacteria in coughed-out sputum samples in less than half an hour. That’s a fraction of the time it takes to diagnose the disease using the most common methods today.
The device, to be marketed under the name TB REaD, is “designed to be really simple and require no technical experience,” said Jeffrey Cirillo, a professor at the Texas A&M Health Science Center College of Medicine who led the product’s development. “We want this to be able to be used anywhere.”
Cirillo’s work – supported by a partnership that includes the Foundation for Innovative New Diagnostics (FIND), the Wellcome Trust, the National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation – is just one example of the kind of innovation made possible by collaborations among non-government organizations, private companies and government bodies in the fight against TB.
Over the last 15 years, such public-private partnerships (PPPs) have revived the crusade against the disease, which still infected almost 9 million people and killed more than a million in 2012 alone, according to the World Health Organization.
PPPs “are absolutely essential,” said Dr. Lucica Ditiu, executive director of the Stop TB Partnership, an international body that coordinates TB efforts around the world. “You cannot go fighting TB without partners.”
A persistent problem
Tuberculosis is a centuries-old, airborne disease that most often attacks the lungs. When left untreated, it can kill up to two-thirds of its victims, according to the WHO. In recent years, strains of drug-resistant TB have surfaced where treatment regimens are mismanaged or not completed, triggering a renewed cry for public awareness and improved care for patients. PPPs, said Ditiu, play a vital role in answering that call.
One of the challenges of treating TB is identifying its existence in the first place. The most common method of diagnosing TB in developing countries today was first discovered more than a hundred years ago. In 1882, a German scientist named Robert Koch developed a way to identify the bacteria that cause the disease. The process, called smear microscopy, involves taking a biological sample such as sputum, fixing it on a glass slide and staining it with a dye that makes the bacteria visible through a microscope. Though an inexpensive test, smear microscopy is time-consuming and relies on the expertise of the person examining the sample for accuracy. In resource-poor settings, the expenses related to hiring and training staff to use smear microscopy may prevent the test from being more widely used.
Drug treatment, too, is inadequate. Even the drugs most often used to treat TB, such as rifampicin and isoniazid, are still those that were developed in the 1950s and 60s to combat the disease, she said.
These dated methods are partly a result of the stigma associated with TB, said Cheri Vincent, chief of the Infectious Diseases Division of the United States Agency for International Development (USAID). “People think, ‘Isn’t that a disease of the past?’”
The TB mortality rate has in fact dropped by 45 percent since 1990 and the rate of new cases has fallen steadily in the last decade, according to the WHO’s Global Tuberculosis Report 2013.
But in parts of South Africa and Asia, where more than half the cases worldwide were reported in 2012, the disease is still a daily concern. And cases of multidrug-resistant (MDR) TB – which takes up to two years of medication to treat – have also slowed progress.
By providing funds and other resources, PPPs are instrumental in keeping efforts against TB alive and rolling, Ditiu said.
A promising PPP
For Cirillo and his team, partnering with the private sector has been invaluable. The researchers not only have received funding from various nonprofit and private foundations, but also have benefitted from working with Global Bio Diagnostics (GBDbio), a Texas A&M spinoff corporation whose goal is to develop, manufacture and sell disease diagnostic devices at low cost.
Finding that GBDbio’s goals lined up with their own, Cirillo and his colleagues partnered up with the company to commercialize the TB REaD device and eventually distribute it to populations that most needed the technology.
TB REaD not only spots small amounts of TB bacteria within a half hour and works even in the most remote, rural village; it also costs just about $500 per unit and less than $5 per patient. Currently, the gold standard – a machine called GeneXpert MTB/RIF – takes one to two hours to process, requires a constant power supply and can cost up to $60,000 per unit.
“You could potentially diagnose [patients] so much more quickly,” Cirillo said of TB REaD. “They can walk away with their antibiotics.”
Though still in prototype form, TB REaD is in the late stages of mostly successful clinical trials being held in the United States, Peru, Vietnam and Thailand, he said, with plans to go to market in the next 18 months.
The partners agree they could not have gone so far without support through PPPs.
“I think for TB efforts [PPPs] are probably a necessary model,” said Michael Norman, co-founder and CEO of GBDbio. “You’ve got to involve this whole gamut of partners in the TB ecosystem.”
The critical role of relationship-building
Funding is just one of the many key functions of PPPs in efforts against TB. They also provide essential support in delivering goods and services, training personnel, encouraging private practices and health centers to participate in the fight, and bringing awareness of the disease to a broader audience.
In South Africa’s mining sector, for instance, which has the highest rate of TB in the world, Stop TB’s Ditiu cites collaboration between her organization and the Global Fund to Fight AIDS, Tuberculosis and Malaria. The partnership resulted in the Declaration on Tuberculosis in the Mining Sector, a commitment by the heads of 15 South African nations to support programs against TB, HIV and other communicable diseases. The partnership has also reached out to some of the region’s biggest mining firms, such as Anglo American and AngloGold Ashanti, and urged them to invest in their workers’ health, said Ditiu.
In another example, GeneXpert MTB/RIF – which can detect both TB bacteria and its resistance to rifampicin, and which TB REaD aims to improve upon – is also a result of a partnership between researchers at the University of Medicine and Dentistry of New Jersey; the molecular diagnostics company, Cepheid, Inc.; the NIH; and the Gates Foundation.
Public-private collaboration has been critical to lowering the cost of GeneXpert, too. In 2012, the United States President’s Emergency Plan for AIDS Relief (PEPFAR), USAID, UNITAID and the Gates Foundation announced a collaboration that ">reduced the cost of GeneXpert for 145 countries with high rates of TB to about $17,000 per unit. The cartridges, used to collect the samples, went from $17 to about $10 apiece. The price cut has helped save $15 million annually for the beneficiaries, according to reports.
Building and strengthening relationships among government divisions, NGOs and the private sector – and uniting them in efforts to stop TB – are crucial as the campaign fights to achieve the UN Millennium Development goal of halting and reversing the spread of the disease, USAID’s Vincent said.
“There’s no way we’re going to get new drugs, diagnostics, resources without the private sector,” she added. “We need people involved on every level.”
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