NEW YORK (360Dx) – Alere has launched a new lateral flow immunoassay for malaria developed with support from the Bill and Melinda Gates Foundation, PATH, and the Foundation for Innovative New Diagnostics, and plans to make the test available in low-resource settings for a price of $1 per test.
The test, called Alere Malaria Ag P.f, has been shown in internal evaluations to have an analytical sensitivity in detecting the histidine rich protein II antigen of Plasmodium falciparum at least 10 times higher than existing rapid diagnostic tests (RDTs), or lateral flow immunoassays, Duncan Blair, Alere's vice president of global health, said. "We leveraged our broad and unique capabilities in lateral flow technology to come up with something that really pushes the barrier in sensitivity for rapid diagnostic lateral flow tests," Blair said.
The overarching goal of the new malaria test development was to create a diagnostic that could detect very low levels of parasitemia, such as those seen in people who are carrying malaria-causing plasmodium parasites but are otherwise asymptomatic.
Detecting the parasite in these patients through screening programs can lead to treatment, and hopefully eliminate the reservoir of infection that perpetuates malaria spread.
"Existing rapid tests cannot do that; they are not sensitive enough. Molecular tests could, in theory, but they are simply not implementable on a broad scale," noted Blair.
Indeed, while a near-patient molecular test from Meridian Biosciences this week showed 100 percent sensitivity and specificity, compared to gold-standard microscopy techniques and RDTs, in studies presented at the European Congress of Clinical Microbiology and Infectious Disease (ECCMID), that test requires an instrument, and electricity, to run and to read, so may be more suited for rapid diagnosis in higher-income settings.
The new Alere test, on the other hand, requires no ancillary equipment, Blair said. After a whole blood sample is applied and a buffer is added, lateral flow does the rest.
"There is no additional equipment — no heating, refrigeration, or cold chain, and no reader, required," Blair said. Alere does develop reader technology, and so there may be reader options for the test in the future, but these will not be necessary because the assay is visually read, Blair said.
In fact, "From an end-user perspective, it is the same as the malaria test they use today ... and that was part of the project from the very beginning, to make this highly deployable in the same way" that current RDTs are being utilized.
The freedom from instrumentation also brings the overall cost to users down compared to molecular tests. The $1 per-test price will be offered to public sector healthcare providers in low-income countries and low-resource settings, and is part of an indefinite "global access commitment" between Alere and the Gates Foundation, Blair said.
He also noted that Alere is not claiming at this time that the test can be used for malaria eradication, but that developing a very sensitive test, which could potentially be used for such efforts, was part of the funding agreement with the Gates Foundation.
Catharina Boehme, CEO of FIND, said in a statement that the new Alere test "is a valuable addition to the malaria elimination toolkit. Looking forward, we are excited to see the results of our forthcoming demonstration studies, as these will provide valuable insights into how this test can have the biggest positive impact."
The funding to support test development included about $2 million from the Gates Foundation, according to a representative there.
Considered to be one of the largest lateral flow assay manufacturers in the world, Alere, Blair said, used its proprietary know-how to make the super-sensitive test.
"We have maybe the biggest lateral flow business in the world, and we have some of the best lateral flow R&D scientists across a range of sites, as well as immunologists, protein chemists, and biologists, so we exploited all of our different sites and individual R&D teams, and asked each of them to push the boundaries within their own domain," Blair said. This included the protein chemistry, antibodies, colloids, conjugation methodology, and manufacturing processes that go into each test, he said.
The enhanced technology can now also be used in other Alere tests, but the firm sees it as best applied to areas where limits of sensitivity are particularly important. For example, "We do have a longer-term vision to develop out the toolkit for malaria, applying this technology across other gaps and needs in diagnostics," Blair said.
Alere is also in the process of obtaining World Health Organization prequalification for the test, as it has done with its qualitative molecular HIV test, in order to further enable uptake in low-resource settings.
WHO has a malaria rapid test evaluation program that operates in rounds, Blair said, evaluating all tests against a standard set of panels. Alere has entered and completed the current round already. This round of evaluations, including Alere's test, is due to be published in the next few weeks or so, Blair said, and the firm expects prequalification — which will enable procurement by government agencies and programs in many parts of the world — to be granted thereafter.
Field studies evaluating the test are also underway. PATH, has submitted field data for publication on assessments in Mozambique and Myanmar, Blair said, showing a higher case yield when specifically targeting asymptomatic, but PCR-positive, individuals in different transmission settings.