How to leverage the superpowers of diagnostics

Dr. Emma Hannay of FIND and Dr. Madhukar Pai of McGill University recently published a Lancet comment on leveraging momentum from the COVID-19 pandemic to expand access to diagnostic testing.

Their comment builds on the findings of the Lancet Commission on Diagnostics (LCD), which highlighted an ever-widening gap in access to basic diagnostic tests at the primary care level between low and middle-income countries (LMIC) and high-income countries (HIC). The authors of the LCD wrote that, “Diagnostics are an essential part of a well-functioning and high- quality health system. Yet, almost half of the global population has little or no access to diagnostics.”

Dr. Hannay and Dr. Pai’s commentary comes at a time when the COVID-19 pandemic has revolutionized access to self-testing by putting diagnostic tests in the hands of hundreds of millions of people around the world.

This presents an opportunity that must be leveraged, wrote Dr. Hannay and Dr. Pai. “This unprecedented level of public engagement and intimate connection with testing could be used to demand better access to diagnostics for other conditions and increase use of testing services for the management of other health conditions.”

However, the increase in availability of diagnostics has been uneven. Only about 39% of COVID tests administered worldwide have been used in LMICs, where about 80% of the global population lives.

Dr. Hannay and Dr. Pai, who are both part of the Innovations and Exemplars in Diagnostics project initiated by Exemplars in Global Health, argue that health systems in LMICs neglect diagnostics at their peril, and that lack of access to diagnostics are increasingly a barrier to treatment.

Exemplars News spoke with Dr. Hannay, who is Chief Access Officer at FIND and also an Exemplars in Global Health Technical Advisory Group member, about diagnostics, including why they are often overlooked and suffer from a lack of investment, and how health leaders can improve access to testing to accelerate progress towards their health goals.

You are concerned with the benign neglect of diagnostics in many LMICs. What’s the impact of this neglect? How is it impacting health outcomes?

Dr. Hannay: I think diagnostics’ superpower is that they are a great enabler of other things.

Testing enables timely diagnosis and linkages to healthcare. Testing enables better quality of care. It enables patients to know about their own health and to make informed decisions about their own health. And it enables good public health responses.

The challenge is: diagnostics are not owned by any one part of health systems. Generally, health policy documents do not feature a section on diagnostics and there is no chief diagnostics officer sitting within ministries of health.

Because of that, testing experiences benign neglect throughout health systems and makes itself known only when it emerges as a major barrier within a vertical program. So, we tend to see improved diagnostic capacity and capability limited to some of the vertical programs. For example, malaria and HIV.

The implications are huge – diagnostics are often the biggest barrier to access.

What progress in diagnostics have you seen recently and, looking ahead, what are you excited about?

Dr. Hannay: One of the small silver linings of the COVID-19 pandemic is that it led to advances in the availability of self-testing and changed the way we think about this technology. COVID self-testing is now the standard around the world. You probably have a box of COVID self-tests in your cupboard. That might not seem strange, but it really is a radical departure from our previous approach to diagnostics. This is very exciting, and we need to build on this momentum from the pandemic.

There has also been tremendous progress in hepatitis C self-testing. Less than 10 years ago, hepatitis C diagnosis was cumbersome and difficult. It required multiple blood tests and treatment monitoring tests. Then a new straightforward oral treatment that was very effective came on board. This accelerated progress in hepatitis C self-testing and getting these tests into communities, especially to groups that are stigmatized within the health systems.

We have to recognize that from HIV to hepatitis C, self-testing is accelerating access to treatment.

The natural tendency of health systems is to control testing access because health leaders want data back and they are very worried about diagnoses happening outside the formal health system. But this should not be either/or. You can have self-testing and data as the COVID-19 response in high performing countries, such as New Zealand and Australia, demonstrated.

The second exciting advancement we see, after the expansion of at-home testing, is the simplification of laboratory technology. If you look at technologies like PCR testing, which is really a workhorse of laboratories, the same can be done for a whole lot of different diseases that historically needed sophisticated laboratory infrastructure.

Today, we see a promising pipeline of products that further simplifies laboratory technology, extending it to home-based molecular testing, which is really a wild advancement in thinking in that space.

This opens the door to further democratization and improved access to testing services. Because simplifying technology means that we can bring diagnostics closer to communities and patients. This is an opportunity for health leaders to ensure that primary health centers and communities can perform tests that were previously the exclusive purview of referral hospitals and central laboratories. But this will not happen absent intervention and deliberate effort from the global community.

Without deliberate investments, our concern is that the gap in access will grow. These diagnostic tools could remain the exclusive domain of high-income countries or wealthy private sector, with no change in access in LMICs.

This equity piece is really important.

Your organization, FIND, has been vocal about broadening manufacturing capability of diagnostics. Can you share how that fits into the picture?

Dr. Hannay: The pandemic really showed how broken public health commodity supply chains were. For example, the world was suddenly critically dependent on two swab manufacturers, one of which was just outside Milan, Italy and the other one was on the East coast of the US. Both countries got hit early in COVID and these factories got shut down. These were the only places in the world that were producing pre-qualified swabs for COVID testing.

Being able to distribute that manufacturing base more widely is really important for global health security and ensuring more countries have autonomy over their own access to commodities. There has been a push from countries like Senegal, South Africa, India, Brazil, and others to change this. But their products have to be able to find a market locally. This is both a demand side and supply side challenge.

In Senegal for example, we’ve been working with DIATROPIX from the Institut Pasteur de Dakar to help serve the local market that is too small to attract a global-level manufacturer but would be interesting for a local or regional manufacturer. For instance, if you are manufacturing a schistosomiasis rapid test in East Africa, you're perfectly placed to serve your local market.

If you want to guarantee that you can access medical countermeasures when you need them, you are going to need to have manufacturing closer to the point of use and you are going to need to generate demand for those tools.

What should health leaders be doing to improve access to diagnostics in their geographies?

Dr. Hannay: First, they need to recognize that diagnostics are at the heart of quality and effective healthcare service delivery. In our comment, we highlight 10 opportunities created by the pandemic that could be leveraged to address the gap in diagnostics. This includes exploring self-testing or home-based sampling collection for other conditions.

Diagnostics has moved from being the exclusive purview of pathologists and laboratories to being everybody’s business within health systems. The tools that help improve access to medicines and vaccines within a health system work well for diagnostics too – collecting good data on what’s truly available in clinics and communities, defining priorities for access, ensuring financing and supply chains work, ensuring staff are well trained and able to use the diagnostic tests provided, and lowering barriers for patients to access tests. We need to bridge this mismatch between how much communities and patients value diagnostic testing, and how much it is prioritized within health systems.

At a political level, health leaders should also explore how we can strengthen private sector cooperation, particularly to establish R&D and regional manufacturing networks for diagnostics and advance digital health solutions that can bridge that connectivity gap for diagnostic data.

At the World Health Assembly this year, a resolution on strengthening diagnostic capacity will be voted on. Passing this resolution will help ensure diagnostic testing is prioritized and resources are mobilized to realize its potential.

Editor's Note:

Exemplars in Global Health is exploring some of the same questions discussed in this interview. This research will cover how Exemplar countries achieved their success in expanding access to testing and will unpack factors that contributed to bridging gaps in access to diagnostics.