GADx is pleased to announce its significant contribution to a groundbreaking study published in PLoS One. The research, titled " Performance of Novel Antibodies for Lipoarabinomannan to Develop Diagnostic Tests for Mycobacterium tuberculosis ," showcases the collaborative efforts of international experts to enhance TB diagnostics. This study evaluates the performance of novel antibodies targeting lipoarabinomannan (LAM), a key component of the Mycobacterium tuberculosis (MTB) cell wall. The work of our team members, James Schouten and Paul Davis, has been instrumental in advancing this important research. Their efforts, along with contributions from other global health organizations, aim to improve the sensitivity and specificity of TB diagnostic tests. James Schouten said: “It was incredibly inspiring to work alongside many valued experts in the field of TB diagnostics. The discovery of novel TB-LAM antibodies with high affinity to target and unique specificities was an exciting development and we look forward to further demonstrating their potential in detecting LAM at clinically relevant levels, with the aim of significantly improving TB diagnosis and patient care.” Key Findings The study assessed 25 new and 4 existing antibodies to find optimal combinations for detecting LAM in the urine of TB patients. Using a multiplex electrochemiluminescence-based liquid immunoassay, the researchers evaluated 841 antibody pairs to identify those offering superior performance compared to existing tests. The results revealed 28 antibody pairs with strong binding affinities, highlighting their potential to significantly enhance TB diagnostic accuracy. This advancement is crucial for developing rapid diagnostic tests (RDTs) effective in resource-limited settings. Despite the identification of several new antibody pairs with high sensitivity to cultured LAM (cLAM), none of the candidates demonstrated increased performance with urinary LAM (uLAM) compared to an existing optimal pair. This finding suggests that further research is needed to develop antibodies that can effectively detect LAM in urine samples from TB patients. Implications for TB Diagnosis Tuberculosis remains a leading cause of death, especially in low- and middle-income countries. The COVID-19 pandemic has further disrupted TB diagnosis and treatment, making the development of rapid and accurate diagnostic tools even more urgent. The antibodies developed through this study promise to facilitate early detection and timely treatment, thereby saving lives and reducing transmission. Collaborative Effort This research underscores the power of global collaboration, involving institutions such as PATH, FIND, various universities, and health institutes worldwide. The project received funding from the Bill & Melinda Gates Foundation and support from the National Institute of Allergy and Infectious Diseases. Increased Demand for Antibodies Since the publication of this study, GADx has seen a surge in enquiries about these novel antibodies. This increased interest reflects the critical need for improved TB diagnostics and the potential impact of our latest advancements. To learn more or to request information, please visit our contact page .  For more information on the study, visit the PLoS One website here .

Global Access Diagnostics (GADx) has been selected as a spoke for the Investor Catalyst Hub, a regional hub of ARPANET-H, a nationwide health innovation network launched by the Advanced Research Projects Agency for Health ( ARPA-H ). Based in the Greater Boston area and managed by VentureWell, the Investor Catalyst Hub seeks to accelerate the commercialization of groundbreaking and accessible biomedical solutions. It utilizes an innovative hub-and-spoke model designed to reach a wide range of nonprofit organizations and Minority-Serving Institutions, with the ultimate aim of delivering scalable healthcare outcomes for all Americans. GADx joins a dynamic nationwide network of organizations aligned to ARPA-H’s overarching mission to improve health outcomes through the following research focus areas: health science futures, proactive health, scalable solutions, and resilient systems. Investor Catalyst Hub spokes represent a broad spectrum of expertise, geographic diversity, and community perspectives. “Our spoke network embodies a rich and representative range of perspectives and expertise,” said Mark Marino, Vice President of Growth Strategy and Development for VentureWell and Project Director for the Investor Catalyst Hub. “Our spokes comprise a diverse network that will be instrumental in ensuring that equitable health solutions reach communities across every state and tribal nation.” As an Investor Catalyst Hub spoke, Global Access Diagnostics gains access to potential funding and flexible contracting for faster award execution compared to traditional government contracts. Spoke membership also offers opportunities to provide input on ARPA-H challenge areas and priorities, along with access to valuable networking opportunities and a robust resource library.  The spoke network will continue to grow as the Investor Catalyst Hub expands its efforts, with applications being selected on a rolling basis. Interested organizations can visit Investor Catalyst Hub to learn more or submit a membership application.

Global Access Diagnostics (GADx), a social enterprise prioritising equitable access to diagnostics, today announced the launch of 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 1 and has since ensured the regulatory requirements have been met for reintroduction to the market. Test reintroduced to the market following regulatory and performance validation for UKCA marking. Launch supports World Health Organization’s strategic plan for the elimination of life-threatening neglected tropical disease. 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 2. 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. In January 2023 3 , 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. Emily Adams, Chief Impact Officer, GADx, commented: “As an impact-led organisation, GADx is committed to developing high quality and affordable diagnostic tests to provide diagnostic capabilities to low-resource areas, allowing treatment of infections to begin more quickly and help save lives. By acquiring the IT LEISH rapid diagnostic test and ensuring it remains accessible to the market, GADx is supporting the WHO’s road map for eliminating NTDs. This work is essential to our mission and vision.”  1. Press release (30 th September 2022): https://www.globalaccessdx.com/global-access-diagnostics-acquires-manufacturing-rights-for-it-leish-rapid-diagnostic-test-from-bio-rad-laboratories 2. https://www.who.int/news-room/fact-sheets/detail/leishmaniasis 3. https://www.who.int/news-room/events/detail/2023/01/24/default-calendar/stakeholders-meeting-for-the-development-of-a-strategic-plan-for-the-elimination-of-visceral-leishmaniasis-in-east-africa

It is with great pleasure that Mologic Ltd t/a Global Access Diagnostics (GADx), announces the appointment of our new CEO, starting 1st February 2024, Dr Mark Street-Docherty. Mark brings with him enormous experience of leading small and medium-sized diagnostic companies in the UK and enters GADx at a time of significant growth. ‘I am delighted to join GADx as their new CEO, and excited to be working with the restructured senior leadership team towards our goals of providing innovation solutions for point-of-care diagnostics.’ – Dr Mark Street-Docherty Mark is a seasoned IVD professional with extensive experience of the design, manufacture and global deployment of clinical diagnostics. He has previously served as CEO and Executive Chair at several UK businesses, including the award-winning Elucigene Diagnostics business. His wide experience of building diagnostics businesses will play an important role in the mission of the parent organization, Global Access Health, to manufacture its products in Africa and South East Asia with local partners. GADx is owned by a consortium of social impact investors called Global Access Health, dedicating its profits and mission to improving the health and wellbeing of underserved populations around the world. Headquartered in Bedford in the United Kingdom, with a US subsidiary situated in Maine, New Gloucester. Since May 2023 GADx has been managed in collaboration with the Clinton Health Access Initiative team’s Dr Randy Allen and Mr Alan Staple, who have brought enormous experience, expertise, and systems. GADx and our Board members are grateful for all their support and commitment during this transition period.  GADx is now entering a period of substantial revenue growth through the delivery of contract product development services of companion diagnostics for top-tier pharmaceutical partners and through delivery on contracts to develop diagnostics and diagnostic technologies for Global Health.

Global Access Health (GAH), a social enterprise dedicated to providing affordable medical products for global health, today formally introduced its first portfolio company, Global Access Diagnostics (GADx). GADx has been created to address gaps in the global provision of diagnostics with a focus on expanding affordable access to quality tests. The Company combines expertise in rapid diagnostics development from Mologic Ltd with low-cost manufacturing and scale-up capability of sister company, Global Access Diagnostics (GAD). GADx combines expertise in the development of rapid diagnostics (Mologic Ltd) with sustainable, volume manufacturing (Global Access Diagnostics) under one organisation First portfolio company of social enterprise Global Access Health (GAH) following acquisition of Mologic Focused on expanding equitable and affordable access to world-class medical technology in low- and middle-income countries, starting with diagnostics Delivering high value scientific research, product development and manufacturing capabilities on terms that advance the mission GADx is a social enterprise where all surplus is re-invested to deliver quality and affordable diagnostics to those in most need. This includes transferring diagnostic technology to low-middle income countries, delivering tests such as COVID-19 to communities in need, and developing tests for neglected diseases such as dengue, bilharzia, and river blindness. It is a unique initiative set up and supported by GAH which was formed in 2021 by a group of philanthropic funds and investors led by the Soros Economic Development Fund (SEDF), with support from the Bill & Melinda Gates Foundation1. Through this transaction, the group acquired Mologic and GAD to harness industry-leading expertise in developing and manufacture of rapid diagnostic technologies. Combining this expertise under the GADx single brand advances the organisation’s philanthropic goals to maximise its contribution to global healthcare. In addition to its product portfolio, GADx offers world-leading expertise for contract research and development, as well as helping companies to scale-up manufacturing (prototyping to pilot-scale) with capacity to produce over 2 million test per day, and then facilitate local manufacturing and/or onward distribution throughout the world. Through decentralized research, development, and manufacturing in and for the Global South, GADx aims to address gaps in the provision of global diagnostics, in regions that profit-focused business has failed to address. “Nearly half of the world’s population have little or no access to diagnostics; and only 1-in-5 people in low and low-middle income countries have basic diagnostic tests available to them.” said Mark Davis, CEO of GADx R&D (formerly Mologic). He added: “GADx’s foundation is based on three pillars: leadership in research and development, manufacturing prowess and Our Core Mission: reinvesting surplus. We are building an innovative social enterprise that puts underserved communities above shareholders and aims to create legacies that bring sustainable change to healthcare and business.” Sumin Koo, CEO of GAH, commented: “To be a leader in R&D, we brought in Mologic, a pioneer in rapid diagnostics and already participants in over 150 international research projects and working with globally recognised partners. The team’s expertise and products are at the forefront of human, animal, and agriculture diagnostics.” Sumin Koo, added: “This is paired with the strength of GAD’s novel manufacturing platform; holding the flexibility and expertise to accommodate one-off orders and scale-up for mass production, over 1million tests per day.”  Mark Radford, CEO of GADx Manufacturing (formerly GAD), added: “This is an exciting next step for GADx, harnessing our individual expertise in lateral flow testing to transform rapid diagnostics. We have very well-established contract manufacturing capabilities to provide custom, flexible and scalable solutions, from low- to high-volume. This single brand portrays our group vision for the future of diagnostic testing, we look forward to progressing this to get the best tests to the most people, for the lowest cost and do so sustainably.”

About Mologic, Ltd. Mologic is a leading developer of advanced lateral flow and rapid diagnostic technologies. Leveraging its core technology platforms, the Company is structured as a social enterprise, working with international organizations across many disease targets, to help deliver fast, reliable and affordable diagnostics globally, at the point-of-care. The creativity, insight and knowledge that led to the first ground-breaking testing inventions in pregnancy and women’s health have guided Mologic since its formation in 2003, underpinning many of the organization’s existing and future innovations.