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· IT-LEISH is widely used to support the diagnosis of visceral leishmaniasis, a neglected tropical disease
· Technology transfer to GADx aims to keep vital test accessible on the market
Bedford, UK, September 2022 – Global Access Diagnostics (GADx), a social enterprise prioritising equitable access to diagnostics and driving local manufacturing, today announced it has acquired the manufacturing rights for the IT-LEISH rapid diagnostic test (RDT) for visceral leishmaniasis (VL) from Bio-Rad, a global leader in life science research and clinical diagnostic products.
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 a trusted RDT, taking only 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.”
ENDS
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About Global Access Diagnostics (GADx)
Global Access Diagnostics (GADx) is a social enterprise prioritising equitable access to diagnostics and driving local manufacturing to create sustainable independent production. GADx is a leading developer of lateral flow and rapid diagnostic technologies, products and services, offering a full suite of services from concept to validation to manufacturing at flexible volumes.
Leveraging our core technology platforms and expertise, we work with companies, researchers and clinicians to help them deliver fast, reliable and accurate diagnosis at the point-of-care. We then facilitate local manufacturing and/or onward distribution throughout the world, with a focus on low- and middle-income countries.
GADx was formed by the acquisition of two companies, Mologic and Global Access Diagnostics, by a consortium of social impact investors called Global Access Health. As part of this transition, GADx became a social enterprise, dedicating its profits and mission to improving the health and wellbeing of underserved populations around the world. We are headquartered in Bedford in the United Kingdom and have a US subsidiary situated in Maine, New Gloucester.
For more information: www.globalaccessdx.com
Mologic Ltd trading as Global Access Diagnostics. Company registered in England and Wales .Company Registration No. 4784437 | All Rights Reserved