What’s in the way of Africawide molecular diagnostic roll out?

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“It really is a game changer.” That’s how Dr. Chanda Chitalu, an infectious disease specialist based in Zambia, refers to molecular diagnostics — a collection of tests that have the ability to assess health “at a cellular and molecular level” following the collection of a blood or saliva sample.

Analysis of the organism’s sequences can pinpoint the potential emergence of cancers, congenital abnormalities, and infectious diseases, including HIV, hepatitis B and C, severe acute respiratory syndromes, and human papillomavirus.

“One of the most important things about molecular diagnostics is making accurate diagnoses,” said Matilu Mwau, deputy director at the Kenya Medical Research Institute, adding that the prescription of the wrong medication can contribute to antimicrobial resistance while a lack of diagnosis can have deadly consequences.

“If a person is not able to access a molecular test at all and you can't make a decision … then [the patient is] going to die sooner or later because you're not going to give them medication that could save their lives,” he said. “Then suppose a person suspects you have HIV and you don't have it and they give you medication for HIV for the rest of your life. It's unthinkable.”

Yet molecular diagnostics aren’t widely available in Africa, the continent with the highest burden and variety of infectious diseases. According to the World Health Organization, the African continent has 25.6 million cases of HIV with access to viral load testing varying greatly while 60 million live with hepatitis B and 10 million endure hepatitis C.

“For Africa, and the low- to middle-income countries … molecular diagnostics are not readily available,” Mwau said. “But if you're in a country like Germany or France, then the likelihood of you getting a molecular diagnostic test for your problem is quite high.”

Many African countries instead rely on examining blood via microscopes to detect parasites or use, when it comes to HIV, “a set of signs and symptoms that have been agreed upon,” Mwau said. This only serves to exacerbate the health disparities between those from higher- and lower-income countries.

Aside from diagnosis, a molecular diagnostic — in the form of a viral load test — plays a critical role in monitoring HIV patients’ response to antiretroviral therapy, or ART, and is considered by WHO to be the “gold standard” for monitoring HIV progress. There are 33.9 to 43.8 million people currently living with HIV globally, two-thirds of whom live in the African region. Among those, 30% on ART don’t have regular access to viral load testing.

Lab training on molecular diagnostic analysis at Livingstone Hospital in Zambia. Photo: Hologic, Inc.

Improving access to such technology would contribute to efforts to achieve key global goals such as UNAIDS 95-95-95 — which aims to have HIV testing, treatment, and viral suppression at a rate of 95% by 2025 — as well as universal health coverage and Sustainable Development Goal 3 on good health and well-being for all by 2030.

“Diagnostics help us to be able to rapidly know what's causing a problem and if it's a transmittable disease, then you can quickly do your infection prevention,” said Chitalu.

Lab training on molecular diagnostic analysis at Livingstone Hospital in Zambia. Photo: Hologic, Inc.

According to research, laboratories that have adopted molecular diagnostics are having a greater impact on the treatment and care of patients. Doctors are able to diagnose diseases at a quicker rate, better monitor them, and adjust treatment, thus, saving lives.

Lab training on molecular diagnostic analysis at Livingstone Hospital in Zambia. Photo: Hologic, Inc.

What’s getting in the way of widespread molecular diagnostics?

The biggest barrier to access in the region, said Hema Srinivasan, chief access officer at MedAccess, is the cost of the technology, its maintenance, and staffing. The tests have an inconsistent price of anywhere between $10 and $85, and with so few governments purchasing the tests, the cost of manufacturing is high and then reflected in the price tag.

Hema Srinavasan explains how the partnership between MedAccess, CHAI and Hologic is helping to ensure more people in Africa can access diagnostic testing for HIV.

“We see high price, low volume traps in these markets,” Srinivasan said. “They have to account for all the risks and uncertainty and what demand could do over time. Because of that, governments are reluctant to expand their purchase volumes and therefore the prices remain high over time.”

An additional barrier, according to Mwau, is the lack of local technical knowledge around molecular diagnostics. “Some of [the tests require] master’s degree- and Ph.D.-level diagnostics. Then some of them are Bachelor's degree level,” he said, explaining that the need for specialized training means there’s often a lack of qualified personnel, particularly in rural areas.

Kabwe Central Hospital in Zambia, where staff have been taking part in a training with the Ministry of Health to scale up HPV testing as part of cervical cancer screening. Photo: Hologic, Inc.

“We need to build a competent pool of laboratory workforce that can easily be deployed where the need is and also the skills to support that scale up of testing when it is needed,” echoed Ndlovu Nqobile, CEO at the African Society for Laboratory Medicine.

While there are a number of initiatives focused on skills development, the challenge, he said, is that they are not yet well coordinated and structured in a way that makes it clear who is being trained and where. “We need to harness it as a continent so that we can track who has been trained and what for,” Nqobile said.

Staff at Kabwe Central Hospital in Zambia take part in a training with the Ministry of Health to scale up HPV testing as part of cervical cancer screening. Photo: Hologic, Inc.

A training group in Kabwe, Zambia — one of multiple courses led by the Ministry of Health that included approximately 140 healthcare workers and lab technologists. Photo: Hologic, Inc.

The third barrier is the supply chain and delivery of the equipment from overseas, said Mwau. “Molecular diagnostics often require elements that are manufactured in the developed world. They need to be shipped to the country. They have temperature requirements … they need to be transported over long distances in a cold chain,” he explained. The logistics and transport need to be supplemented with training on how to perform the tests, which all amounts to additional financing.

But access must improve, said Chitalu. “We need to up our game in terms of molecular diagnostics to be able to know the behavior of emerging infectious diseases, to be able to diagnose them, to treat them, and also to prevent them. We need to increase access to these tests to be able to help us to achieve these aims,” he said.

Enter a solution

One initiative working to ensure global access to innovative diagnostic and monitoring technology is the Global Access Initiative. Launched in 2018 by global health care and diagnostics company Hologic in partnership with MedAccess and the Clinton Health Access Initiative — and backed by the government of the United Kingdom — GAI is a program that aims to reduce the cost of diagnostic testing for HIV/AIDS, hepatitis, and cervical cancer for more than 180 million individuals living in low- and middle-income countries.

The program works by using a volume guarantee for molecular tests on the Panther system — a sample-to-result molecular diagnostic automation machine — as part of an all-inclusive pricing model that covers the installation of the machine, training, service, reagents and consumables, freight and logistics for a reduced cost of a maximum $12 per patient test with no upfront costs or capital expenditure from governments required. The guarantee reduces uncertainty of quantity, brings prices down, and ensures a sustainable increase in funded demand that allows manufacturers to keep expanding the business, sustain low prices, and increase accessibility, MedAccess’s Srinivasan said. At the same time it encourages governments to make the purchase.

Ministry of Health launched nationwide trainings to scale up cervical cancer screening in Zambia. Photo: Hologic, Inc.

Lab staff participants in a cervical cancer training led by the Ministry of Health of Zambia. Photo: Hologic, Inc.

A training group in Lusaka, Zambia — one of multiple courses led by the Ministry of Health that included approximately 140 healthcare workers and lab technologists. Photo: Hologic, Inc.

Such market shaping, she believes, is critical when there are systemic barriers that are not easily resolved by a quick investment.

“In the case of molecular diagnostics … we really felt like there needed to be a critical shift in the way that the market was structured and the way procurement was run,” she said. “We felt it was important for purchasers to move to all-inclusive pricing agreements that accounted for everything that was needed to deliver viral load test results to a patient.”

So far, over 80 Panther system instruments have been introduced in 13 countries in the region — including in Zambia, Botswana, and Kenya — while over 200 training sessions have been delivered to strengthen the skills and competencies of the laboratory workforce. This has enabled 13 African countries to strengthen their molecular diagnostics capacity, paving the way for access to lifesaving testing for more than 8.8 million people.

“We estimate over 500,000 people have improved clinical outcomes in managing their HIV disease,” Srinivasan said. “That makes a really big difference in terms of ending the HIV epidemic.”

HIV viral load testing has also seen a 15%-50% price reduction, culminating in an annual cost saving of $27 million. This initial success is encouraging countries to use the technology to address co-infections and integrate testing for other diseases, according to Hologic.

The Panther system can use a single sample to conduct multiple tests for various diseases. This is important in reducing the need for multiple tests and in tackling co-infections. In West and Central Africa, 12% of people living with HIV also have hepatitis B.

“We need to move towards integrated testing services … In doing so, we are able to deliver more with less,” Nqobile said.

Over the coming years, GAI plans to scale up testing for HPV and hepatitis B and C and to expand to 33 other countries including Cote d’Ivoire, Cameroon, and Ghana, as well as parts of Asia and Latin America.

Africawide roll out, Nqobile said, would enable timely detection of outbreaks and mean significant advances toward universal health care.

“There's no reason to do guesswork in the 21st century,” Mwau said. “Countries should go full out to adopt this technology.”

What’s in the way of Africawide molecular diagnostic roll out?

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What’s getting in the way of widespread molecular diagnostics?

Enter a solution

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