NEW YORK – With no signs that the global coronavirus pandemic is waning, the World Health Organization is on a mission to raise $6 billion for the diagnostics arm of its Access to COVID-19 Tools-Accelerator program over the next year, with initial funding going toward the development and deployment of rapid viral antigen-based tests.
The WHO provided details of its plans last week at a media event during which it discussed each of the four pillars of the ACT-A collaborative effort — vaccines, therapeutics, diagnostics, and health integration. The organization also laid out an overall investment case for $31.3 billion to promote equitable global access to healthcare during the pandemic.
A partnership between the Foundation for Innovative New Diagnostics (FIND) and The Global Fund to Fight AIDS, Tuberculosis and Malaria is overseeing the ACT-A diagnostics program, which will focus initially on scaling up point-of-care SARS-CoV-2 viral antigen testing capacity for 500 million people.
The diagnostics pillar is also composed of members from international organizations, such as UNICEF and UNITAID, and other organizations like the African CDC, the Bill and Melinda Gates Foundation, the Praesens Foundation, and the Clinton Health Access Initiative.
Peter Sands, the executive director of The Global Fund, is co-leading the ACT Accelerator partnership on diagnostics along with FIND's Catharina Boehme. At the media event last week, Sands outlined the $6 billion investment case for the diagnostics pillar of the program.
"That is a combination of money we need to accelerate R&D and market preparedness, and money to help low- and middle-income countries procure and deploy" testing, Sands said during the event, adding that "$2 billion is needed right now."
Specifically, the diagnostics arm is immediately seeking $300 million to identify and support development of rapid COVID-19 diagnostic tools, and $100 million for market preparedness activities like regulatory support and manufacturing scale-up.
An additional $300 million will help strengthen health systems in low- and middle-income countries, while $1.3 billion will support initial pooled procurement of tests in LMICs. Ultimately, an additional $5 billion is estimated to be needed down the line for the procurement and delivery of tests.
Containing the COVID-19 epidemic in LMICs will need to rely more on testing, tracing, and isolation than on quarantines, Sands said, since socioeconomic factors make lockdowns unsustainable in many LMICs.
"Households don't have the wherewithal to continue without working, and countries and governments don't have the ability to compensate for lost income," he said. "Coupled with that, the clinical care facilities are extremely limited — many African countries, for example, have very limited ICU capacity.
"The starting point is very rapid rollout of very large numbers of tests," Sands said.
The diagnostics pillar is already up and running, he said, "procuring and supplying several million COVID-19 tests to LMICs every month," and also engaged with country partners on strengthening laboratory capacity.
In addition to a focus on rapid tests, other goals of the project include accelerating regional production, and development of a non-proprietary test result reader.
"Ultimately, we want to see at least 500 million tests delivered in low- and middle-income countries over the next 12 months, and we need at least 10,000 healthcare workers trained to help in that delivery," Sands emphasized.
Last week, WHO said it had raised $3.4 billion to support ACT-A, but a fundraising event last weekend in partnership with Global Citizen raised an additional $6.9 billion, including pledges and a $5.4 billion loan and guarantee commitment from the European Commission and the European Investment Bank.
Viral antigen tests under consideration
The fund initiative comes amid signs that the pandemic could be around for an extended period as parts of the Americas, south Asia, and Africa see a tick-up in the number of reported COVID-19 cases.
"We all want this to be over. We all want to get on with our lives. But the hard reality is, this is not even close to being over," WHO Director General Tedros Adhanom Ghebreyesus said at a media briefing on Monday.
The ACT-A diagnostics pillar's current priority is to identify and evaluate viral antigen-based diagnostics, FIND CSO Ranga Sampath said in an interview this week.
The WHO is in the final process of defining the target product profile, and in parallel FIND on behalf of ACT-A is evaluating commercial tests and seeking out candidates in development. So far, there don't seem to be any tests that are yet ready for prime time, Sampath said.
"There are many that are promising, but none that we could say 'These two companies' products meet all the needs and would be the ones that we scale up,'" he said.
FIND is currently evaluating five commercially available rapid antigen tests and is in discussions with a number of manufacturers that are developing assays.
The tests under evaluation are from Belgium-based Coris BioConcept, China-based Shenzhen Bioeasy Biotechnology, South Korea-based RapiGEN, and two tests from SD Biosensor, also a South Korea-based firm.
The official evaluation is not yet public, but Sampath noted that a few of these first-generation antigen RDTs don't currently meet the performance characteristics that the ACT-A diagnostics team is seeking, particularly in terms of sensitivity. "They have promise, but they won't meet all the needs," he said.
A handful of commercial manufacturers and research groups have either launched viral antigen tests or described tests in development, as previously reported. For example, OraSure has said it is developing a viral antigen RDT test that it expects to launch in the Fall.
FIND is also currently tracking commercial antigen-based tests through its SARS-CoV-2 diagnostics pipeline, and Sampath said it is aware of approximately 20 promising candidates in development, including antigen RDTs from BioNote, Mologic, and DCN Dx.
The ACT-A diagnostics team is pushing for late summer or early fall to begin making products available.
The group is relying on modeling data suggesting viral antigen rapid diagnostic tests may be the best way to reach the most people. Within LMICs, there is less ability to carry out traditional decentralized molecular testing because it is either unavailable or is too slow or costly, Sampath said. He estimated that three quarters of the tests required will be "easy-to-deploy" diagnostics, which would most likely be antigen-based RDTs.
However, antigen tests that require platforms or readers — such as the recently-launched Quidel Sofia 2 SARS Antigen FIA for example, or an antigen test in development on the BD Veritor — generally require a lab space in LMICs, Sampath said.
"If you have a lab, then the base case is slightly different, and you could then look at smaller point-of-care molecular diagnostics to see how they perform," he said. Tests for viral nucleic acids — which generally incorporate an amplification step — are typically more sensitive than diagnostic tests that simply react to antigen on the viral surface.
"Right now, we are prioritizing antigen RDTs as a first shot … keeping in mind that there is still a huge need for point-of-care molecular tests and there are markets where these tests can be used, so also ensuring that they are scaled and produced will be a critical piece," Sampath said.
Although the initial ACT-A call is for 500 million tests, that is simply the amount needed to target LMICs, Sampath clarified. "Globally, the need it much larger."
Indeed, the pandemic is straining higher-income countries as they try to manage shortfalls in testing capacities.
"We believe that the products coming out of this [effort] would, and should, focus broadly — what we want is that a percent of the development be focused to ensure equitable delivery and access to LMICs," Sampath noted.
That said, a reliable, fast, point-of-care antigen test "would be a game changer" in higher-income countries as well, he said, and these same products could also be used in such settings. The difference would be that in LMICs there is less opportunity for confirmatory molecular testing, so the accuracy of the RDTs might be more critical in that context.
In addition to the viral antigen-based test assessments, FIND has also been performing and publishing the results of other assay evaluations.
It provided details last week on a first round of 21 molecular diagnostic assays for SARS-CoV-2 in which the tests showed high sensitivities and specificities and limits of detection between 1 and 100 copies per milliliter, consistent with a number of recent studies. FIND is also currently evaluating a total of 26 rapid serological antibody tests and eight ELISAs to detect past COVID-19 infection.