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.

纽约——MagIA Diagnostics将于1月启动一个为期三年的项目，开发和实施艾滋病毒、乙型肝炎和梅毒的即时检测，可在撒哈拉以南非洲等地区部署，以减少怀孕期间母婴疾病的传播。

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.

该公司总部位于法国阿尔卑斯山格勒诺布尔以外，与其合作伙伴已获得500万欧元（520万美元）用于实施该项目，该项目由欧盟地平线欧洲计划资助。该项目被称为“传染病联合筛查的创新护理点：应用于预防母婴传播”，缩写为MAGFA，将于1月1日开始运行。

1, 2025, through Dec. 31, 2027..

2025年1月至2027年12月31日。。

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.

MagIA首席执行官保罗·考夫曼（PaulKauffmann）表示，作为该项目的一部分，该公司旨在开发两种免疫检测方法，一种用于筛查艾滋病毒、肝炎和梅毒，另一种用于诊断患有乙型肝炎的孕妇，以便她们接受治疗。

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..

这两项新测试都将在MforScreen上运行，MforScreen是一种3公斤重的即时分析仪，可提供多路测试，充电间隔电池寿命为8小时。该平台允许每次测定测试10个靶标，并且可以在不到15分钟内运行。根据考夫曼的说法，每个MagIA测试盒都需要50微升的血液样本进行分析。。

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..

MagIA已经设计了第一个名为MagIA IBC的小组，其目标是针对HIV 1和2以及乙型和丙型肝炎。其目标是现在添加梅毒标记，并与撒哈拉以南非洲的合作伙伴在不同环境中测试产生的测试，称为MagIA IBS，那里的温度或湿度可能会影响测试结果。。

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.

新测试还将评估其在可能存在其他感染的血液样本中辨别这些感染的能力。它将用于孕妇的现场，其减少母婴传播的能力也将作为该项目的一部分进行评估。

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..

考夫曼说，针对梅毒螺旋体（一种引起梅毒的细菌）特异性抗原的检测方法的第一个概念验证是在今年早些时候开发的。考夫曼说，这证实了该技术能够应用于“广泛的生物测定”。他说，梅毒的加入是MagIA发展计划中的“关键”，因为在其菜单中加入这种检测方法将使该公司不仅可以为中低收入国家的孕妇筛查提供梅毒，还可以为欧洲高危人群提供梅毒筛查。。

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.'

考夫曼指出，由于所有检测都是独立进行的，因此不会发生交叉反应。他说，这使该公司能够“采取模块化的方法来扩展其面板，而无需重新开发所有内容。”

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.

MagIA计划在新项目期间开发第二种检测方法，针对肝酶丙氨酸氨基转移酶和乙型肝炎病毒蛋白HBeAg，将其用作乙型肝炎检测和治疗方法的一部分，并减少母婴传播。考夫曼（Kauffmann）说，第二项测试名为TREATB，将“使感染HBV的孕妇接受预防性治疗，以避免病毒在围产期传播”。这两种检测方法都将由非洲合作伙伴进行评估。

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.

肯尼亚医学研究所和科特迪瓦艾滋病和其他传染病诊断研究中心将首先在中央实验室环境中评估测试。。

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..

刚果民主共和国四个不同省份的大约7500名孕妇将在产前咨询期间接受检测，随后将对检测结果进行分析。。

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.

考夫曼（Kauffmann）说，他认为MagIA的检测将是对传统免疫检测方法的改进，传统免疫检测方法检测单一传染病，这意味着它们需要多次手指穿刺和多次孵育才能覆盖同一光谱考夫曼说，这些都是错误的来源，在咨询过程中很难处理。

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..

多次测试也没有共同的保质期或储存条件，进一步阻碍了它们的使用。此外，他补充道，迄今为止，目标之间的交叉反应阻碍了创建多重测试的尝试。。

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.

一些公司一直试图以不同的方式满足相同的市场需求。例如，Chembio Diagnostics在其DPP HIV梅毒系统上提供了HIV和梅毒的双靶点检测。该公司总部位于纽约州的Hauppauge，去年被法国测试制造商Biosynex收购。

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.

同时，加拿大生物实验室在其INSTI多重HIV-1/2梅毒抗体测试中提供了针对HIV和梅毒的侧向流动产品。随着近年来性病病例数量的激增，此类疾病受到了诊断制造商的极大关注。

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.'.

关于乙型肝炎病毒，考夫曼指出，确认该疾病需要一个PCR和生物化学肝脏专家组，由于昂贵的试剂和后勤问题，成本可能高达150欧元，这使得撒哈拉以南非洲的母亲成本过高。MagIA diagnostics提供了一种即时检测方法，可以诊断患有乙型肝炎的孕妇，并允许她们在怀孕期间接受治疗，因此MagIA diagnostics希望其检测能够“大大限制母亲将乙型肝炎病毒传播给新生儿的机会”。

Magnetic immunoassays

磁性免疫分析

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.

考夫曼自2017年联合创立MagIA Diagnostics以来，一直领导该公司。该公司的产品基于法国国家科学研究中心（CNRS）和格勒诺布尔阿尔卑斯大学（UniversitéGrenoble Alpes）进行的研究。顾名思义，该公司的平台依赖于经过十五年磨练的磁性免疫分析技术。

Kauffmann was a project leader in different companies in the US and France before setting up MagIA. .

在成立MagIA之前，考夫曼是美国和法国不同公司的项目负责人。。

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.

据考夫曼（Kauffmann）介绍，法国研究人员开发了一种方法，可以将纳米颗粒局部捕获到微磁上，并将这些结构应用于不同的应用，其中包括免疫测定。

'This technology enables us to massively parallelize immunoassays without any complex fluid handling, thereby enabling low-cost production of our consumables,' he noted.

他指出：“这项技术使我们能够大规模并行化免疫分析，而无需任何复杂的流体处理，从而实现低成本生产消耗品。”。

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.

该技术后来被转移到格勒诺布尔阿尔卑斯大学（UniversitéGrenoble Alpes）的创业孵化器Linksium，然后该公司于2017年开始其针对常见性传播感染开发低成本即时免疫检测的使命。由私人资助，MagIA迄今已筹集约600万欧元。

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)..

考夫曼（Kauffmann）指出，MagIA继续与CNRS和格勒诺布尔阿尔卑斯大学（UniversitéGrenoble Alpes）合作，并有兴趣开发利用相同微磁技术检测通过PCR或环介导等温扩增（LAMP）扩增的DNA的检测方法。。

'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.

考夫曼（Kauffmann）说：“我们的目标是提供一种即时检测分析仪，它可以同时进行免疫分析和分子检测，以覆盖传染病检测中更广泛的面板。”目前正在开发这种技术。

Regulatory outlook

监管展望

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.

根据考夫曼（Kauffmann）的说法，根据欧洲体外诊断法规，MagIA的免疫检测被归类为D类设备，这意味着它们需要经过通知机构的评估。他说，MagIA Diagnostics目前正在对其IBC测试进行临床验证，该测试可能在明年年底之前根据IVDR获得CE-IVD标记。

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..

MagIA预计到2026年底其IBS测试将获得CE-IVD分数，到2027年TREATB将获得CE-IVD分数。该公司还将提供一种艾滋病毒、乙型肝炎和丙型肝炎以及梅毒测试，称为IBC，它打算与IBS测试同时推出，并将在2026年寻求CE-IVD标记。。

'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..

考夫曼说，我们一直在与我们的通报机构密切合作，以确保我们（IBC）测试的监管策略。他指出，这包括两步临床验证：一步是对大量样本进行回顾性验证，另一步是有望证明每个声称的样本矩阵的临床表现。。

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..

就成本而言，考夫曼表示，MagIA正在计划与欧洲的性病诊所和社区中心建立试剂租赁业务模式，在那里，MforScreen将承诺每年购买1000套试剂，每套试剂的价格约为18欧元。在撒哈拉以南非洲和类似市场，由于试剂盒数量预计会增加，测试价格将降低。。

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.

至于美国，考夫曼表示，MagIA愿意与体外诊断公司建立战略合作伙伴关系，这可能有助于它进入美国市场。