Delivering a lateral flow diagnostic test to market is a huge challenge. By leveraging contract research organisations (CRO) with expertise in development we can accelerate your success. In this post, we explore the key moments for bringing in a CRO which can bridge expertise gaps, streamline development, reduce internal strain, and introduce innovative solutions. To illustrate these key moments, we highlight GADx’s expertise as a contract research organisation. Our clients use these key areas as a baseline to determine the type of CRO services required for their diagnostic discovery and ultimate success on the market. 1. Bridging Expertise Gaps Complex lateral flow diagnostics often require specialist expertise—such as antibody screening, custom chemistry, or device prototyping . GADx bridges these gaps, providing direct access to our expertise. At GADx, our scientists bring experience across protein identification, antibody characterisation, assay development, and more, ensuring projects progress efficiently and avoid common pitfalls. In supporting your product development GADx ensures you have access to the best available platforms, materials and methods. Organisations can fast-track their progress with ready-to-use expertise that guarantees quality and problem-solving capability. Our antibody production capabilities are an especially critical resource. With hundreds of successfully developed antibodies, GADx offers recombinant antibodies, epitope mapping, and monoclonal production tailored to your project needs. These capabilities help clients bridge expertise gaps quickly, avoiding the need to invest time and resources into building these skills in-house. Over many years that GADx has been at the forefront of innovative lateral flow test development, we have forged close relationships with the leading service providers in antibody production. When necessary, we design the required immunogens for you, and our trusted antibody deliver the antibodies ready to go. Working with GADx brings the benefits of these established connections. 2. Early Development: Accelerating from Concept to Prototype The early stages of developing a lateral flow test often appear to be relatively straightforward but are critical and require foresight into final usability and use case. Eventual performance of the test will be defined by these first steps, so developers carry a huge responsibility to ‘get it right’. This is where an assay development partner can be critical for the overall project. Having access to a wide range of materials, methods and know-how helps to cut time for assay design and construction, delivering prototypes that work and will require little optimisation. We bring into the conversation considerations of material choice and availability, sample processing, manufacturability, and result capture – to ensure it delivers on the intended customer usage. There is no doubt about it, setting off on the right path will reduce the overall development time. Engaging GADx as your CRO streamlines reagent selection, assay optimisation, and prototyping, allowing your team to focus on core innovations instead of getting bogged down by technical challenges. Many early diagnostic projects face a steep learning curve when tackling complex targets. By leveraging GADx’s expertise, organisations can tap into proven workflows and methodologies, avoiding the delays and costs associated with trial-and-error. 3. Reducing In-House Burdens Managing multiple projects can easily overwhelm even well-resourced R&D teams. A CRO can help by taking on your project, effectively acting as an extension of your team. This helps balance workloads, ensures milestones are met, and allows your team to stay focused on their primary activities and for your product to flourish. Many companies underestimate the effort required for specialised tasks such as antibody screening , epitope mapping or end user feasibility. A CRO can manage these tasks, allowing your core team to focus on their strengths. This also prevents employee overload and increases overall productivity by enabling teams to work more efficiently. Additionally, GADx’s expertise extends beyond antibodies to device prototyping and design, including rapid prototyping using 3D printing to create custom housings that integrate sample collection and processing. By entrusting these specialised tasks to a CRO with a proven track record, you avoid the need for internal staff to face steep learning curves or struggle with unfamiliar methods. 4. Mitigating Risk with a Stage-Gated Approach A stage-gated approach ensures each phase of development is validated before moving forward, reducing the risk of costly errors. GADx provides structured oversight, especially during proof-of-concept and prototyping phases, to minimise risk and support data-driven decisions. All products progress through our stage-gated review system, from Phase 0-5, within the scope of a Quality Management System (ours or yours). You can be reassured that all our work is carried out in accordance with our ISO13485 certification. The stage-gated approach allows you to make go/no-go decisions based on reliable data. GADx brings a disciplined process that avoids the pitfalls of rushing through development stages. Additionally, this structure helps build a sense of partnership , as each completed stage provides tangible progress and data that builds confidence among investors and other stakeholders. 5. Scaling Up: From Lab Bench to Production Scaling diagnostics from lab to production requires attention to quality control and regulatory compliance. GADx can manage this transition, supporting small- to mid-volume manufacturing and ensuring smooth technical transfer, while allowing you to focus on market strategy and commercialisation. The GADx contract research team provides insights into best practices for scaling up, identifying potential production bottlenecks early and ensuring processes are scalable without compromising quality. GADx also helps navigate the regulatory landscape, ensuring your product meets compliance standards from the outset, reducing the risk of setbacks during commercialisation. A CRO partner needs to be able to support your product journey from start to end, whether the market requirement is in the thousands or the millions. GADx has created a network of manufacturing partners around the globe who are ready to take on production of tests to the highest quality. The journey from concept to market of your lateral flow product will be safe in GADx’s hands and allow your concept, product and impact to be realised. Why to Engage a CRO Consider engaging a CRO if: Expertise Gaps: accessing specialised skills not available in-house. Accelerated Timeline Requirements : Timelines are tight, and speed to market is critical. Risk Management : Your project has significant technical risks that require rigorous validation. Quality Management System and ISO 13485 certified environment for product development and manufacture. Regulatory Navigation : You need support to manage complex regulatory requirements and ensure compliance. Clinical Trials Organisation : Our Clinical trials team can help you design and carry out your trials to IVDR and WHO standards Conclusion: Strategic Partnerships for Success Engaging a CRO is about building a strategic partnership to complement your in-house capabilities. Whether it’s early research, bridging expertise gaps, or scaling up production, a CRO can help you move forward efficiently. In diagnostics, where time, quality, and accuracy matter most, GADx can make all the difference. With the right CRO, you can mitigate risks, fast-track development, and ultimately bring innovative diagnostics to market with confidence. Our extensive experience in antibody development, custom chemistry, device prototyping, and data-backed methodologies at GADx provide the tools you need to navigate complex diagnostics successfully. Let us help you leverage our expertise to bring your diagnostic solutions to life. Ready to accelerate your diagnostic development? Partner with GADx to leverage our extensive expertise in assay design, assay optimisation, and small-scale manufacturing. Contact us today to discuss how we can help bring your diagnostic solutions to life.

In the ongoing fight against Crimean-Congo Haemorrhagic Fever (CCHF), Global Access Diagnostics (GADx) has joined forces with the Liverpool School of Tropical Medicine and international experts to develop a rapid diagnostic test (RDT) tailored for use in endemic settings. Published in eBioMedicine , this research showcases a critical advancement in tackling one of the world’s most challenging viral threats. CCHF is a tick-borne disease with a mortality rate as high as 30%, and it disproportionately affects rural communities where access to medical infrastructure may be scarce. Diagnostics for CCHF rely on complex lab-based methods, leaving frontline health workers with limited tools to manage outbreaks effectively. Addressing this, the newly developed RDT provides a faster, simpler solution that could shift the paradigm of CCHF detection. What the Results Say—and Why They Matter The prototype RDT’s performance was rigorously evaluated in Türkiye and Iraq, delivering promising results: Türkiye : The test demonstrated a remarkable sensitivity of 90.4% and specificity of 96.2% in prospectively collected clinical samples. These figures not only meet but exceed the World Health Organization’s (WHO) benchmark for CCHF diagnostics. Iraq : While the sensitivity in retrospective samples was slightly lower at 71.7%, the specificity remained high at 92.5%. Importantly, the test achieved 100% sensitivity in high-viral-load cases (cycle thresholds ≤20), highlighting its effectiveness in the most urgent scenarios. The takeaway? This RDT could be a game-changer in the early detection of cases, enabling swift action to prevent the disease’s spread and save lives. GADx’s Role in Driving Innovation This achievement was due to the collaborative nature of the approach— and GADx’s contributions were instrumental in several key areas: Technological Expertise & Collaboration : GADx lent its deep knowledge in monoclonal antibody development and lateral flow test design to ensure the RDT was both reliable and adaptable. LSTM staff and PhD students were able to collaborate and join GADx in our laboratories for development. Optimisation and Training : The company worked closely with key opinion leaders and healthcare teams to refine the test, optimise its accuracy, and ensure smooth implementation in real-world conditions. Global Perspective : Drawing on its experience in diagnostics for underserved regions, GADx helped shape the RDT into a tool that fits the needs of the most vulnerable communities.What’s Next? Turning Potential into Reality While these results are exciting, the work is far from over. The team is already looking ahead to the next phases of development: Expanding trials to include diverse geographies, ensuring the RDT’s reliability across viral strains and settings. Adapting the test for whole blood samples, making it even more practical for point-of-care use. Conducting cross-reactivity studies to confirm specificity and rule out interference from other pathogens common in endemic regions. Planning for full-scale IVDR-compliant clinical evaluations of the design-locked device in endemic settings. The goal? A diagnostic tool that is not only effective but also affordable, scalable, and ready to meet the realities of rural healthcare. A Collective Step Forward in Global Health This collaboration highlights what’s possible when expertise, resources, and a shared commitment to global health come together. For GADx, being part of this effort is both a privilege and a responsibility—a chance to contribute to a future where diagnostics are no longer a barrier to health equity. The RDT may not solve every challenge posed by CCHF, but it represents hope: hope for faster diagnoses, better patient outcomes, and a stronger defense against future outbreaks. At GADx, we’re proud to be part of this story, and we remain committed to advancing diagnostics that make a difference where they matter most. GADx and LSTM would like to acknowledge funding from the NIHR HPRU for Emerging and Zoonotic diseases and The Pandemic Institute who made this programme possible.

On world COPD day, GADx is delighted to introduce our prototype test, (Headstart), a remote patient monitoring platform measuring five biomarkers in urine. Headstart is being evaluated to identify early or confirm the first signs of exacerbation with sufficient reliability and clarity for the patient to know when to seek medical attention or not. Early recognition and prompt treatment can result in reduced hospitalisations and improved clinical and economic outcomes. COPD affects over 400 million people worldwide and is predicted to be the third leading cause of death by 2030. COPD is characterised by daily symptoms of breathlessness, cough and wheeze with persistent impairment in lung function tests. At times there is worsening of the symptoms leading to exacerbations. Exacerbations are caused by several triggers including viral and bacterial infections but also due to a series of smaller perturbations culminating in destabilisation of the disease. COPD exacerbations can be harmful because they can cause further damage to the lungs therefore, preventing an exacerbation from occurring can improve quality of life and reduce risk of death. Most measurements of inflammation in COPD have focused upon sampling blood or sputum at the time of the exacerbation compared to stable visits several weeks apart. These approaches have not led to an adopted test due to lack of sensitivity and specificity and challenges in obtaining the samples at times that could then alter management. The challenge is to develop near patient tests that can measure and deconvolute the heterogeneous inflammatory response that precede the clinical presentation of an exacerbation. GADx have partnered with a number of experts along the way ranging from statisticians, bioinformaticians App developers, reader developers, clinical teams, health economic specialists, funding institutions, we have collectively been able to make breakthrough progress in the development of this technology. Today, on World COPD day , we are proud to announce that our paper ‘’Artificial neural network risk prediction of chronic obstructive pulmonary disease (COPD) exacerbations using urine biomarkers’’ has been published in ERJ Open Research. Link to press release. Our findings suggests that the identified urine biomarkers are promising in discriminating COPD exacerbations from stable COPD, can be measured at home with a lateral flow reader and mobile technology and can identify biological changes as early as 7 days prior to a clinical diagnosis of a COPD exacerbation. Further trials are required to validate the test and demonstrate cost-effectiveness and improved health outcomes. Professor Chris Brightling from the University of Leicester, UK, which is part of the National Institute for Health and Social Care Leicester Biomedical Research Centre said: “It would be better if we could predict an attack before it happens and then personalise treatment to either prevent the attack or reduce its impact. We wanted to develop a predictive test that would act like a personal weather forecast of an impending flare-up. We need to do more work to refine the AI algorithm with data from a bigger group of patients. We hope this will allow us to create AI testing for COPD patients that will learn what is ‘normal’ for each person and forecast a flare up in symptoms’’ Dr Gita Parekh, Head of Respiratory at GADx commented ‘’Every COPD exacerbation leaves behind permanent, irreversible lung damage. Headstart is being evaluated to predict exacerbations by detecting biological changes before signs of symptoms and before patient damage has occurred. A test that can help to slow the rate of disease, keep those living with COPD stable and reduce the risk of serious health complications is game changing. We thank everyone who has been involved and supported us throughout the years, it has been a team effort, all working towards the same goal – improving the quality of life for people living with COPD’’

Norbrook, a leader in animal health for over 50 years, is proud to announce the launch of a groundbreaking diagnostic test for liver fluke. Norbrook in cooperation with The University of Liverpool and Global Access Diagnostics (GADx) have developed this innovative tool to address one of the most common agricultural parasite infections in cattle and sheep. Prevalent in over 70 countries worldwide, liver fluke is estimated to cause over US 3.2 billion dollars in livestock production losses. This easy-to-use kit will empower farmers to take control of their livestock health and pasture management. Each antibody test kit contains enough components to conduct 10 separate liver fluke tests. This innovative test will provide veterinary surgeons and farmers with a range of benefits: Convenience : The test kit is portable, easy to transport and designed to be carried out on-farm Speed : Test results will be available in 10 minutes. Current liver fluke diagnostic tests require laboratory analysis Easy-to-use : No specialised training is required; simply follow the in-pack or online instructions Early Identification: The rapid, accurate results will provide veterinary surgeons and farmers with evidence of infection from as early as two weeks Targeted treatment: Early fluke detection will allow veterinary surgeons and farmers to make better informed decisions around appropriate treatment options

Global Access Diagnostics (GADx) is thrilled to announce that we have been awarded the grand cash prize for our at-home urinary tract infection diagnostic by the National Institutes of Health’s (NIH) RADx Tech for Maternal Health Challenge. This prestigious recognition highlights our commitment to improving maternal health outcomes, particularly for postpartum individuals living in maternity care deserts. Revolutionising UTI Diagnostics for New Mothers Urinary tract infections (UTIs) can significantly impact postpartum women, especially those who have undergone catheterisation during or after delivery. Our rapid home test, UTRiPLEX, aims to address this issue head-on by offering an accessible, accurate, and easy-to-use diagnostic solution. Originally designed for healthcare professionals, our innovation was adapted during the RADx Tech challenge to be more user-friendly for at-home testing, much like a traditional pregnancy test. Key Features of UTRiPLEX: Ease of Use: The test has an ergonomic handle and distinct shape outlines around the control and test lines, simplifying use for individuals without medical training. Quick Results: It provides fast detection of active infections, allowing for prompt treatment and reducing the time spent waiting for diagnosis. On-Device Results Key: A results key on the device makes interpretation simple, without the need for any additional instructions or materials. Accuracy: UTRiPLEX is designed to be more precise than current over-the-counter (OTC) solutions, ensuring that mothers can trust the results they receive. Upon regulatory approval, UTRiPLEX will be available over the counter, providing mothers the ability to diagnose and treat UTIs early, without the need for in-person GP appointments. Please note: UTRiPLEX is a prototype device, and its performance has not yet been fully established or authorised for sale. A Mission for Global Health Andrew Wheeler, General Manager at GADx, USA, emphasises our broader mission: “Maternal health challenges transcend borders—they affect women globally, regardless of geography or economics. With UTRiPLEX, we aim to bring meaningful change, providing accessible diagnostic tools to all, whether they’re in a high-tech hospital or a remote village. Improving maternal health outcomes is at the core of our mission to make quality diagnostics accessible for everyone.” Shoutout to Our Incredible Team None of this would have been possible without the dedication and hard work of our amazing team members. Their expertise, passion, and unwavering commitment to advancing maternal health have been instrumental in our success. Looking Ahead We are excited to continue pushing the boundaries of what’s possible in maternal health diagnostics. With the support of the RADx Tech for Maternal Health Challenge, our mission to make quality, accessible healthcare available to mothers everywhere is just beginning. We believe that every mother deserves the peace of mind that comes from knowing her health is in good hands, and we will keep innovating to make that vision a reality. The GADx Team

Dr. Kevin Land, the Head of Innovative Research and Development at Global Access Diagnostics (GADx), delivered a compelling keynote at the prestigious POCT Leipzig conference on April 17, 2024. The event, hosted by the Fraunhofer Institute for Cell Therapy and Immunology, brought together leading experts, researchers, and industry professionals to discuss the latest advancements in point-of-care testing (POCT) and its critical role in global health. POCT Leipzig 2024 POCT Leipzig is an annual event that serves as a vital platform for sharing knowledge and fostering collaborations aimed at improving diagnostic capabilities worldwide. This year, the conference was held over two days, April 17-18, at the Fraunhofer Institute in Leipzig, Germany. It featured a diverse program, including keynote speeches, poster sessions, and industry presentations. The attendees included renowned researchers, clinical practitioners, and industry leaders who are at the forefront of developing and implementing innovative POCT technologies. POCT aims to address current challenges and future directions in the field, with a particular focus on enhancing diagnostic accessibility and effectiveness in low- and middle-income countries (LMICs). Highlights from Dr. Land’s Presentation In his keynote titled “POCT for Global Health: Innovating for the Future,” Dr. Land emphasised the transformative potential of point-of-care diagnostics, particularly in LMICs. He addressed several critical areas where POCT can make a significant impact: HIV Diagnostics and the 90-90-90 Targets: Dr. Land discussed the United Nations’ 90-90-90 targets for HIV, which aim to have 90% of all people living with HIV know their status, 90% of those diagnosed receive sustained antiretroviral therapy, and 90% of those on therapy achieve viral suppression by 2030. He highlighted the importance of accurate and accessible diagnostic tools in achieving these targets and noted the significant strides made in reducing new HIV cases. Tuberculosis Diagnostic Needs: The presentation also covered the global targets set by the WHO for TB, focusing on the necessity for rapid molecular diagnostic tests. Dr. Land pointed out that while current coverage of rapid diagnostic testing for TB is around 47%, there is a goal to reach 100% by 2027. This underscores the need for innovative, affordable, and accessible diagnostic solutions. Safe Drinking Water: Addressing the critical need for safe drinking water, Dr. Land explained that bacterial contamination remains a significant risk in many communities. He stressed the necessity for rapid and reliable diagnostic tests to ensure water safety and prevent disease outbreaks. Lessons from Covid-19: Dr. Land shared insights from the Covid-19 pandemic, particularly the challenges faced by LMICs in terms of diagnostic capabilities. He noted the critical lack of local manufacturing capabilities and the slow turnaround times for PCR tests, which hampered effective testing, tracking, and isolation efforts. The pandemic highlighted the urgent need for faster, more accessible diagnostic tests. The REASSURED Criteria: Dr. Land introduced the REASSURED criteria—Real-time connectivity, Ease of sample collection, Affordable, Sensitive, Specific, User-friendly, Rapid and Robust, Environmentally friendly and Equipment-free, and Deliverable—which GADx uses to guide the development of diagnostics. These criteria ensure that diagnostic tests are not only effective but also accessible and practical for use in resource-limited settings. Innovations in Diagnostic Technologies: The keynote also covered various innovative technologies being explored by GADx, such as printed sensors, cloud storage, 3D printing, and mobile connectivity. These advancements have the potential to significantly impact the field of diagnostics by making tests more affordable, rapid, and accessible. The Future of POCT Dr. Land concluded his keynote by emphasising the immense opportunities that lie ahead in the field of POCT. He called for continued investment in research and development, as well as strong collaborations between stakeholders, to overcome the challenges and make a meaningful impact on global health. The POCT Leipzig conference served as a vital platform for sharing knowledge and fostering collaborations aimed at improving diagnostic capabilities worldwide. Dr. Land’s insights and the innovative approaches of GADx underscore the critical role of point-of-care testing in enhancing healthcare outcomes, particularly in underserved regions. For more information about the POCT Leipzig conference and the work of Dr. Kevin Land and GADx, visit the POCT Meeting website . Interested in learning more about how GADx’s innovative solutions can benefit your organisation or community? Contact us today to discuss our range of products and services, and how we can work together to advance global health diagnostics.

GADx, in partnership with an international consortium , is revolutionising healthcare in low- and middle-income countries through the HOLICARE project . HOLICARE is a groundbreaking initiative established to improve the diagnosis of respiratory tract infections (RTIs), addressing current challenges in low- and middle-income countries. RTIs are a leading cause of death among infectious diseases worldwide (reference WHO). They are one of the major Poverty-Related Diseases (PRDs), representing 40% of deaths and 17% of cases reported in Sub-Saharan Africa with 2.4 million deaths caused by RTIs reported in 2016. The project converges around four pillars: diagnostics, network and resources, academy, and access. While GADx plays a role in all pillars, our focus is on the development of lateral flow diagnostic tests for COVID-19, influenza, and respiratory syncytial virus, with the goal of having these tests transferred for manufacture in Sub-Saharan Africa.

Considering ADLM but not sure if it’s right for you? Find out if it should be on your radar as we share our experiences. The Association for Diagnostic Laboratory Medicine (ADLM) conference is the go-to event for professionals across the laboratory medicine spectrum. In 2024, it once again provided a vital platform for researchers and clinicians to share their latest findings and innovations. At the heart of ADLM, the Expo offered attendees a unique opportunity to explore cutting-edge solutions, engage directly with industry leaders, and discover innovative products shaping the future of diagnostic testing and patient care. The event felt alive, with a staggering 24% surge in attendance – a clear indication of the industry’s eagerness to innovate and connect after the challenges of the pandemic. As diagnostic developments gather momentum, ADLM stands out as a beacon of progress, a place where ideas flow, partnerships are made, and the future of healthcare takes shape. GADx at ADLM At the heart of this year’s event, the GADx team was in the thick of it, soaking up the energy and sharing our vision for accessible, affordable diagnostics. Our team included Rwanda Boone, Andrew Wheeler, Devon LaPlante, and Paul Meakin (UK), engaging with attendees and industry peers on the bustling Expo floor. Andrew captured the energy of the event with this excellent video:

Mologic (D/B/A Global Access Diagnostics: GADx) is pleased to announce its collaboration on an important study with Johns Hopkins University, recently published in Scientific Reports. The research, titled “ The Development of Lateral Flow Devices for Urinary Biomarkers to Assess Kidney Health, ” represents a significant step forward in the field of kidney health diagnostics. GADx team members Anya Gregg, Qianyi Liu, Andre Albert, and Andrew Wheeler contributed their expertise to this collaborative effort, working alongside researchers from Johns Hopkins University led by Dr. Chirag R. Parikh and his team. This partnership underscores GADx’s commitment to advancing healthcare through innovative diagnostic solutions while highlighting the importance of academic-industry collaborations in driving medical research forward. Key Findings The study developed lateral flow devices (LFDs) for detecting two key urinary biomarkers: Uromodulin (UMOD) and Osteopontin (OPN). These biomarkers may play important roles in assessing kidney health in various contexts, including kidney transplantation. The newly developed LFDs demonstrated the following detection limits: UMOD: Lower limit of detection at 80,000 pg/mL OPN: Lower limit of detection at 8,600 pg/mL  Importantly, the study validated these LFDs using both standard solutions and human urine samples, indicating potential for real-world applications. Potential Applications and Impact on Kidney Health Assessment The LFDs developed in this study offer a potential new approach to assessing kidney function, which could complement existing methods. This new approach aims to provide informative assessments of kidney function, with several potential applications in nephrology: Transplant Optimization: These LFDs could potentially provide rapid assessments of kidney quality in deceased donors, which may help inform organ allocation decisions and improve transplant outcomes. Post-Transplant Monitoring: Regular monitoring of UMOD and OPN levels in transplant recipients could potentially allow for earlier detection of complications or rejection, enabling timely interventions. Chronic Kidney Disease Management: These LFDs may offer a non-invasive way to monitor disease progression and treatment efficacy in patients with chronic kidney disease, potentially improving long-term care strategies. Acute Kidney Injury Detection: In emergency settings, the ability to quickly assess kidney function could be crucial, potentially allowing for faster diagnosis and treatment of acute kidney injury. Research Applications: These LFDs could potentially accelerate kidney research by providing a quick, cost-effective method for assessing kidney health in large-scale studies, furthering our understanding of kidney diseases and treatments. The applications described above are speculative and based on the current research findings. Further studies will be needed to validate these potential uses of the LFDs in kidney health assessment. By offering a potential new tool for kidney health assessment, this research opens up possibilities for more personalized and timely care in nephrology. If validated through further research, these advancements could contribute to improved patient outcomes and more efficient healthcare delivery in kidney health. Moving Forward This study marks an important step in kidney health diagnostics research. GADx is interested in further exploring the potential of these LFDs, with the long-term goal of advancing kidney health assessment tools. We are working towards a future where accurate kidney health assessment could be more widely accessible, potentially leading to improved patient outcomes and more efficient healthcare delivery. To learn more about GADx’s diagnostic capabilities or to inquire about potential collaborations, please visit our contact page .