From Diagnostics to Access

Question 1

What have those years taught you about the biggest barriers preventing advanced diagnostic technologies from reaching the people who need them most across Africa?

Affordability, accessibility, funding gaps and weak regulatory oversight are among the biggest barriers to the penetration of quality diagnostic technologies in low- and middle-income settings across Africa.

Manufacturers, as profit-oriented enterprises, naturally allocate capital to research and development where there is a reasonable margin and return on investment. That is reflected in pricing, which may remain unaffordable for large parts of the population, many of whom are uninsured and rely on daily subsistence income to meet out-of-pocket health expenditure. Low demand can then reduce revenue and further disincentivise investment in product development.

Infrastructure is another major constraint. Gaps in roads, rail, electricity, cold-chain storage and digital networks mean that many communities still struggle to access diagnostic technologies. At primary healthcare level, where patients often first enter the health system, non-portable technologies and models that depend on advanced laboratory infrastructure or centralised testing can make timely access and follow-up much more difficult.

Primary healthcare centres are therefore better served by portable technologies capable of delivering accurate results within a single patient visit wherever possible.

The healthcare funding gap also leaves many countries heavily dependent on international donors and multilateral interventions for diseases that have a major effect on population health. Greater domestic investment in research and development for priority diseases could help change that.

Regulatory capacity matters as well. Weak oversight can allow products of variable quality to enter markets. Supply chains need regular auditing, and diagnostics should increasingly be treated as a distinct regulatory category rather than simply being absorbed into pharmaceutical and food regulatory systems. The rapid evolution of diagnostics over the past decade or two makes stronger specialist regulatory capacity increasingly important.

Question 2

A diagnostic technology can be scientifically excellent and still fail to achieve population-level impact. Beyond the test itself, what needs to be in place for molecular diagnostics to become genuinely accessible and sustainable within African health systems?

Diagnostic innovations intended for the region need to be deployable in rugged settings characterised by difficult terrain, unreliable electricity, limited internet access and inadequate laboratory infrastructure.

They also need to take account of shortages in skilled laboratory manpower and make training practical for the healthcare workers who are available. New devices should be designed around the infrastructure gap rather than assuming that stable electricity, digital connectivity and sophisticated laboratory systems are always present.

For example, technologies capable of operating with solar power could potentially be deployed at primary healthcare centres, where the diagnostic gap is often widest and where the population impact could therefore be greatest.

Pricing must also be sustainable both for manufacturers and for the people who need the tests. Government policies that expand health-insurance coverage could improve access to quality diagnostics and healthcare more broadly. In short, accessibility and affordability have to be core design considerations, not afterthoughts.

Question 3

Cervical cancer remains one of the clearest examples of the gap between available technology and equitable access. From your experience with HPV molecular testing, where do you see the greatest opportunities now for African countries to expand high-performance cervical cancer screening?

HPV molecular testing gives African health systems an opportunity to expand high-performance cervical screening without depending exclusively on infrastructure-heavy cytology systems or on less sensitive approaches such as visual inspection with acetic acid.

Self-sampling is particularly important. Women can collect their own samples and send them to a laboratory, with performance that can approach clinician-collected sampling when validated methods are used. This can reduce some of the stigma and clinical barriers associated with screening and may make participation more acceptable in settings where religious, social or practical sensitivities have limited access.

The wider opportunity is to reach populations that have previously been missed through screening models that are more affordable and less dependent on extensive laboratory infrastructure.

Where testing models can return results quickly - potentially within the same day - they may also reduce loss to follow-up after a positive result. Longer screening intervals associated with HPV DNA-based strategies can further reduce the number of repeat tests required over time and may lower the long-term cost burden for public health systems.

Question 4

The conversation around African health technology is increasingly moving from importing products towards localisation, local manufacturing and stronger regional supply chains. How important do you believe this transition will be, and what would it take for localisation to succeed without compromising quality?

Localisation requires more than installing production capacity. It depends on technology transfer, appropriate intellectual-property arrangements and stringent quality-control mechanisms.

The sanctity and enforcement of contractual and financial obligations are also important. Where there is a perception of weak rule of law or excessive bureaucracy in enforcing agreements, that can make technology-transfer partnerships more difficult.

International organisations can sometimes help de-risk these arrangements. UN agencies such as Unitaid have supported initiatives that encourage procurement of locally manufactured diagnostics, and those kinds of interventions can help create the conditions for localisation to succeed.

Governments can also participate as third parties in technology-transfer negotiations, act as guarantors of minimum purchase volumes, offer tax incentives, and provide the regulatory and industrial ecosystem needed for local production to become commercially viable.

Question 5

Looking ahead five to ten years, what would you most like to see change in Africa’s molecular diagnostics landscape, and what would convince you that the continent has moved from simply adopting technologies to building resilient diagnostic ecosystems of its own?

Africa has the world’s largest proportion of young people and remains a major frontier for global economic development. Greater adoption of molecular technologies, particularly in diagnostics, can expand markets while also creating significant health and economic benefits.

The growth of precision-diagnostics start-ups in countries such as Nigeria, Ghana and Kenya is an encouraging sign that the continent is beginning to build more of its own capability.

But there is still much more to do in local manufacturing. That includes not only finished molecular diagnostic kits, but also basic enabling components such as polymerase enzymes and master mixes. Local production could reduce costs, strengthen self-sufficiency and build greater research capacity across the continent.

Over the next five to ten years, stronger and more specialised regulatory institutions will also be important to supervise and strengthen the production, distribution and use of diagnostics in different African markets.