Global Access Diagnostics (GADx), a social enterprise prioritising equitable access to diagnostics and driving local manufacturing, has acquired the manufacturing rights for the IT-LEISH rapid diagnostic test (RDT) for visceral leishmaniasis (VL) from Bio-Rad, a research and clinical diagnostic specialist.
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Promastigotes of Leishmania parasite which cause leishmaniasis, 3D illustration
IT-LEISH is a high-performance, immuno-chromatographic RDT that is used for the diagnosis of VL, a life-threatening vector-borne disease transmitted by phlebotomine sandflies. Early VL diagnosis is a vital component of controlling the disease which can be fatal if left untreated, and the IT-LEISH product has been independently verified as the most sensitive test available on the market, especially in East African and South American settings.
Having been on the market for over a decade, IT-LEISH is an RDT that takes 20 minutes to generate results and can be performed in any field situation with minimal training. It provides reliable and accurate confirmation of clinically suspected cases of VL that importantly enables early initiation of treatment. In accordance with its mission, GADx will harness its expertise in lateral flow development and manufacturing to restart the manufacture of the high-quality test, retaining the same critical suppliers to offer the product to buyers at an affordable cost-to-market, including smaller-scale production batch sizes to meet the needs of neglected tropic disease (NTD) markets, such as VL.
Having acquired the legal manufacturer status from Bio-Rad, IT-LEISH will be available directly from GADx in April 2023. The Companies are currently working together on the technology transfer of the test.
Mark Davis, CEO of GADx R&D, said: “As a signatory of the Kigali Declaration, GADx is committed to prioritising the development and manufacture of lateral flow devices for NTDs. Without continued manufacture of the IT-LEISH, the WHO’s 2021-2030 road map for NTDs in alignment with the Sustainable Development Goals would be under threat. Over the past decade, Bio-Rad has ensured the availability of this rapid test for the detection of antibodies against Leishmania. By acquiring the legal manufacturing responsibility for IT-LEISH from Bio-Rad, we are upholding this pledge and keeping a vital test accessible to the market whilst contributing towards the diagnosis and elimination of VL. GADx continues to expand the product portfolio to help solve pressing health needs, for deployment in areas of greatest need.”
