An international alliance to solve diagnostics' low-visibility issue?

A Lancet commission is calling for the creation of an international diagnostics alliance by the end of 2022 that would help raise the profile of diagnostics, which have not received as much attention as medicines and vaccines in global health.

Apart from raising awareness about the importance of diagnostics, the commission envisions the alliance to also help set goals — such as that 90% of the population should have access to basic diagnostics within two hours of where they live — and monitor progress against them, as well as gather more data on diagnostics, including their affordability.

The alliance should also link diagnostics to pandemic preparedness, antimicrobial resistance, and health security, Susan Horton, a professor at the School of Public Health and Health Systems in the University of Waterloo in Canada and deputy chair of the Lancet Commission on Diagnostics, told Devex via email.

The alliance could take various forms. It could follow in the footsteps of Gavi, the Vaccine Alliance, or provide a unified focus on diagnostics building on efforts for specific diseases, such as those of the Union for International Cancer Control. It could also conduct research and advocacy to expand access to diagnostics the way nongovernmental organization Health Action International does for medicines, and which is “badly needed for diagnostics,” she said.

The alliance could also build on a collaboration the World Health Organization and the Foundation for Innovative New Diagnostics, or FIND, agreed to in February 2020 for boosting access to essential diagnostics in low- and middle-income countries, by bringing in other stakeholders, including international and nongovernmental organizations, patient advocates, the private sector, and associations of medical professionals, to support the work of national governments, Horton added.

But the key to its success is invoking political will, Horton said, which could be a challenge given the low visibility that diagnostics has received globally. A concrete example: There was no mention of diagnostics in the Sustainable Development Goals.

“I definitely think that the silence on diagnostics in the SDGs for example has made it less likely that national governments will give it priority,” she said.

“The low visibility [of diagnostics] is at the root of what needs to change,” she said.

Attention and data gaps

Kenneth Fleming, chair of the Lancet Commission on Diagnostics, said it’s a mystery why diagnostics have received little attention.

“Given the centrality of diagnostics[,] why are they not front and centre? For example if pathology is mentioned, most people think of "dead bodies" which is but a tiny part of what we do,” he told Devex in an emailed response.

“My personal bias is that this is at least partly a failure of leadership of the diagnostics community. There is a caricature that diagnostics people are reticent shrinking violets. Like all caricatures this carries an element of truth. Diagnostics is the underpinning of all medicine. We have just not celebrated how vital and all pervasive what we do is,” he said.

But the commission’s latest report could help bring more attention to the importance of diagnostics by providing a comprehensive picture of the diagnostic situation globally, including filling some data gaps.

“We have quantified the extent of the lack [of diagnostics] and its impact much more than previously. Data have been a black hole,” Fleming said.

In its report, the commission estimates that 47% of the world’s population has little to no access to even the most basic diagnostics. In low- and lower-middle-income countries, its estimate is that access is at 19%.

Looking at diagnostics access for six health conditions — diabetes, high blood pressure, HIV, and tuberculosis in the general population, and hepatitis B infection and syphilis among pregnant women — it found that the diagnostic gap ranges from 35% to 62%, indicating that about half of the people suffering from these conditions are undiagnosed, according to the report. But if that gap is reduced to 10%, 1.1 million deaths could be averted annually globally.

The commission also outlined the benefit-cost ratio of investing in diagnostics for the six health conditions. For all six conditions, except for high blood pressure, a dollar invested in diagnostics provided benefits in cost savings and future productivity ranging from $1.40 to $24, depending on the disease condition, Horton said.

“COVID-19 has made everyone aware of the need for testing; and we have done our best to provide data, and a comprehensive and authoritative analysis of what needs to be done. And without action on diagnostics, Universal Health Coverage, a key component of the SDG 3, will be much less successful,” she said.

Innovative financing for diagnostics

Apart from an international diagnostics alliance, the commission also recommends that countries develop a national diagnostic strategy; ensure point-of-care diagnostic tests, such as ultrasound, are made available in primary health care centers; expand their health workforce; and strengthen national regulatory frameworks to ensure diagnostic safety and quality.

In addition, apart from a more efficient use of resources, such as regional pooled procurement of diagnostics tools, and support for diagnostic production in low- and middle-income countries to make them more affordable, the commission also recommends tapping into other sources of financing, such as sin taxes, social impact bonds, and development impact bonds.

“DIBs and SIBs are relatively new and have not yet been used directly for diagnostics. The Rajasthan DIB [in India] was used to improve the accreditation of facilities for care of pregnant women, which could (indirectly) improve availability of diagnostics; and the Cameroonian DIB for eye surgery (cataracts) had a provision to tie some of the payments to reaching poor patients - which again could indirectly encourage diagnosis of cataracts in these patients,” said Horton.

The commission also recommends the adoption of a World Health Assembly resolution on diagnostics.

“We understand that it is too late in the timeline to be included in the 2022 WHA, but in promoting the Report's findings we are aiming to create the momentum for a 2023 WHA Resolution,” Horton said.