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Global Access Diagnostics reintroduces IT-Leish test for visceral leishmaniasis

Global Access Diagnostics (GADx), a social enterprise prioritising equitable access to diagnostics, has introduced IT-Leish, a rapid diagnostic test (RDT) for visceral leishmaniasis (VL). The company acquired the manufacturing rights for IT-Leish from Bio-Rad in September 2022 to prevent its withdrawal from the market and has since ensured the regulatory requirements have been met for reintroduction to the market. 

IT-Leish is a high-performance, immuno-chromatographic RDT that is used for the diagnosis of VL, a life-threatening neglected tropical disease (NTD) transmitted by phlebotomine sandflies. Early VL diagnosis is a vital component of controlling the disease, which is considered fatal if not treated rapidly. IT-Leish is a trusted RDT, taking 20 minutes to generate results. It provides reliable and accurate confirmation of clinically suspected cases of VL to enable early diagnosis, reducing disease fatality.

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In January 2023, the WHO announced the development of a strategic plan to review the current epidemiological situation in East Africa, with regional and country-level elimination targets for 2023-2027. As part of this and the WHO’s wider 2021-2030 road map for NTDs, plans will be drawn to ensure long-term and sustainable financing and the procurement of medical supplies, including first-line diagnostics. By harnessing its expertise in lateral flow development and manufacturing, GADx has ensured IT-Leish is fit for regulatory purposes and available on the market as UKCA marked to support these critical campaigns.

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