NEW YORK – MagIA Diagnostics in January will begin a three-year project to develop and implement point-of-care tests for HIV, hepatitis B, and syphilis that can be deployed in regions like sub-Saharan Africa in order to reduce mother-to-child disease transmission during pregnancy.
The company, based outside of Grenoble in the French Alps, together with its partners has received €5 million ($5.2 million) to pursue the project, which is funded through the EU's Horizon Europe program. The project, dubbed "Innovative point of care for combined screening of infectious diseases: application to prevention of mother to child transmission," is abbreviated as MAGFA and will run from Jan. 1, 2025, through Dec. 31, 2027.
MagIA CEO Paul Kauffmann said that the firm aims to develop two immunoassays as part of the project, one for screening for HIV, hepatitis, and syphilis and another to diagnose expectant mothers with hepatitis B, so that they can undergo treatment.
Both new tests will run on MforScreen, a 3-kilogram, point-of-care analyzer that offers multiplexed testing and has a battery life of eight hours in between charging. The platform allows for the testing of 10 targets per assay and can be run in less than 15 minutes. According to Kauffmann, each MagIA test cartridge relies on a 50-microliter blood sample for analysis.
MagIA has already designed a first panel called MagIA IBC which targets HIV 1 and 2 and hepatitis B and C. Its goal is to now add a marker for syphilis, as well as to test the resulting test, dubbed MagIA IBS, in different environments with partners in sub-Saharan Africa, where temperature or humidity could potentially impact the test results.
The new test will also be assessed for its ability to discern these infections in blood samples where other infections might be present. It will be used in the field with pregnant women, and its ability to reduce mother-to-child transmission will also be assessed as part of this project.
Kauffmann said that the first proof of concept for an assay targeting antigens specific to treponema pallidum, the bacteria that causes syphilis, was developed earlier this year. This confirmed the capability of the technology to be applied to "a wide panel of bioassays," said Kauffmann. He said that the addition of syphilis is "key" in MagIA's development plans, as having such an assay in its menu will allow the company to offer it not only for the screening of pregnant women in low- and middle-income countries but also among higher risk groups in Europe.
As all assays are independently performed, cross reactions don’t occur, Kauffmann pointed out. He said this has allowed the company to "take a modular approach to expanding its panel without redeveloping everything."
MagIA plans to develop a second assay during the new project that will target the liver enzyme alanine aminotransferase and the hepatitis B viral protein HBeAg, which will be used as part of a test-and-treat approach for hepatitis B and to decrease mother-to-child transmission. This second test, called TREATB, will "orient HBV-infected pregnant women toward prophylactic treatment to avoid any perinatal transmission of the virus," said Kauffmann.Both assays will be evaluated by African partners. The Kenya Medical Research Institute and the Diagnostic and Research Center on AIDS and Other Infectious Diseases in Côte d'Ivoire will first assess the tests in a central laboratory setting. They will then be validated in the field by Gardiens de Vies, a health-focused NGO based in the Democratic Republic of Congo. About 7,500 pregnant women in four different provinces in the DRC will have the tests administered during prenatal consultations and the performance of the tests will be subsequently analyzed.
Kauffmann said that he believes MagIA's tests will be an improvement upon conventional immunoassays which test for single infectious diseases, meaning that they require multiple finger pricks and multiple incubation times to cover the same spectrum. "These are a source of error and hard to handle during a consultation," Kauffmann said. Multiple tests also don't have a shared shelf life or storage conditions, further impeding their use. Additionally, attempts to create multiplexed tests thus far have been hindered by cross-reactivity between targets, he added.
Some companies have been trying to address the same market need in different ways. Chembio Diagnostics, for example, offers a two-target test for HIV and syphilis on its DPP HIV-Syphilis System. Based in Hauppauge, New York, the company was acquired by French test maker Biosynex last year.
Meanwhile, Canada's BioLytical Laboratories offers a lateral flow product for HIV and syphilis in its INSTI Multiplex HIV-1/2 Syphilis Antibody Test. As the number of STI cases have soared in recent years, such diseases have received significant attention from diagnostics makers.
With regards to the hepatitis B virus, Kauffmann noted that confirming the disease requires a PCR and biochemistry liver panel, which can cost as much as €150 due to expensive reagents and logistical issues, making it cost-prohibitive for mothers in sub-Saharan Africa. By offering a point-of-care test that can diagnose expectant mothers with hepatitis B, allowing them to receive treatment during their pregnancy, MagIA diagnostics hopes its tests will be able to "drastically limit the chance of mothers transmitting HBV to newborns."
Magnetic immunoassays
Kauffmann has led MagIA Diagnostics since he cofounded the firm in 2017. The company's offering is based on research undertaken at the French National Center for Scientific Research (CNRS) as well as at Université Grenoble Alpes. As the company's name implies, its platform relies on magnetic immunoassay technology honed over a decade and a half. Kauffmann was a project leader in different companies in the US and France before setting up MagIA.
According to Kauffmann, the French researchers developed a way to locally capture nanoparticles onto micromagnets and to apply these constructions in different applications, among them immunoassays.
"This technology enables us to massively parallelize immunoassays without any complex fluid handling, thereby enabling low-cost production of our consumables," he noted.
The technology was later moved into Linksium, a startup incubator at Université Grenoble Alpes, before the company embarked on its mission to develop low-cost, point-of-care immunoassays targeting common sexually transmitted infections in 2017. Privately funded, MagIA has raised about €6 million to date. Kauffmann noted that MagIA has continued its partnership with CNRS and Université Grenoble Alpes and is interested in developing assays that would rely on the same micromagnet technology to detect DNA amplified by PCR or loop-mediated isothermal amplification (LAMP).
"The ambition is to offer a point-of-care analyzer that would perform both immunoassay and molecular tests to cover a wider range of panels in infectious disease testing," Kauffmann said, adding work to develop such technology is ongoing.
Regulatory outlook
According to Kauffmann, MagIA's immunoassays are classified as Class D devices under Europe's In Vitro Diagnostic Regulation, which means they need to undergo assessment by a notified body. He said that MagIA Diagnostics is currently performing a clinical validation of its IBC test, which could receive a CE-IVD mark under the IVDR by the end of next year. MagIA expects a CE-IVD mark for its IBS test by the end of 2026 and one for TREATB by 2027. The company will also offer a test for HIV, hepatitis B and C, as well as syphilis, called IBCS, that it intends to launch concurrently with its IBS test and for which it will also seek a CE-IVD mark in 2026.
"We have been working closely with our notified body to secure the regulatory strategy of our [IBC] test," Kauffmann said. He noted that this has included two-step clinical validations: one that is retrospective on a large panel of samples and one that is prospective to demonstrate the clinical performance on each claimed sample matrix.
In terms of cost, Kauffmann said that MagIA is planning a reagent-rental business model with STI clinics and community centers in Europe, where the MforScreen would be placed with a commitment to buy 1,000 kits per year, with each kit priced at about €18. In sub-Saharan Africa and similar markets, test prices would be reduced as kit volumes are expected to be higher.
And as for the US, Kauffmann said that MagIA is open to strategic partnerships with in vitro diagnostics companies that could help it enter the market there.