From Concept to Market: Accelerating Diagnostic Innovation
We design, develop and manufacture lateral flow and diagnostic tests from early feasibility to validated product.
Global Access Diagnostics (GADx) delivers end-to-end diagnostic commercialisation and development services for human, veterinary and plant health applications. From feasibility studies to manufacturing scale-up, we turn your diagnostic concepts into market-ready products.
Comprehensive Solutions
From concept to clinical deployment, we support every stage of your diagnostic journey with specialized expertise and proven methodologies.
Feasibility
Studies
You have a diagnostic idea and need proof that it can work.
- What this covers
You have an idea for a new diagnostic and need proof that it can work. GADx helps transform that idea into an early proof of concept test, delivering precise biomarker measurement across diverse sample types encompassing human, veterinarian and plant health. From antibody discovery and high throughput assessment to expertly choreographed assay design, enabling multi-biomarker quantitative/qualitative detection, our scientists develop assays that deliver the right balance of specificity and sensitivity, ready to move into the next stage of development.
With deep experience across human, veterinary and plant health, every study is designed for manufacturability, regulatory readiness (ISO13485 accredited) and cost-effectiveness, ensuring your concept is both scientifically sound and commercially viable.
Diagnostic Product Development
You have a working concept and need to turn it into a validated diagnostic product.
- What this covers
Through rapid quantitative/qualitative lateral flow test development and GADx help science-driven organisations progress early proof of concept biomarker tests through to manufacturing transfer and fully validated prototypes/products. From expertly choreographed assay design to product/test kit development and the development of product files for country registrations, GADx have the technical expertise enabling precise quantitative biomarker measurement across diverse sample types; supported by clinical, regulatory and quality functions.
When your product development is completed, you can be assured of its analytical/clinical performance, stability and robustness to specifically detect the biomarker(s) of interest. GADx work to ISO 13485 regulatory standards, ensuring that the design history file is completed according to the required launch country regulations
Companion & Therapeutic Services
You have a therapy and need the right diagnostic to support it.
- What this covers
GADx can help science-driven organisations achieve faster diagnostics through AI-enhanced rapid quantitative lateral flow test development and expertly choreographed assay design, enabling precise biomarker measurement across diverse sample types. GADx have proven expertise in the development of research use only, clinical trial monitoring tests and companion diagnostics to support and complement therapeutic and prophylactic medicines for human and animal health.
Whether you wish to simplify the selection of patients for clinical trials, monitor drug levels / side effects or empower patients to track their response to therapy, GADx will work with you to create the perfect companion diagnostic for your drug. From ELISA, for application on a high throughput laboratory platform, to point of care lateral flow tests, GADx have the technical, clinical, regulatory and quality experience required.
We also develop tests to determine antibody status prior to and/or following vaccination with the ability to distinguish between vaccine elicited and natural immunity.
Technology Transfer & Scale-Up
You need to move from the lab to manufacture without losing performance.
- What this covers
We pride ourselves in seamless transfer of products from the R&D bench through to scaled manufacture with one of our strategic partners. GADx technical transfer team work closely with the R&D team during product development and with our external manufacturing partners, to ensure the scaled manufacture retains all of the required characteristics of the test.
During the Technical Transfer process, the ability to consistently manufacture multiple batches to the product requirements is demonstrated using validated QC processes along with analytical verification and clinical validation data, and all necessary manufacturing, regulatory and quality documentation is prepared.
Verification
& Validation
You need robust analytical and clinical evidence before regulatory submission.
- What this covers
GADx are able to conduct or support the analytical and clinical performance assessments required for your diagnostic test, aligned to the appropriate regulatory requirements. From the preparation of performance evaluation plans and detailed protocols, through analytical testing and stability assessment in validated temperature and humidity controlled incubators to reporting, GADx have the experience required to fulfil the requirements for your regulatory submission.
The diagnostic performance of your test will be assessed thoroughly to ensure that it meets the design input criteria before sending out for clinical validation against the gold standard. You can be confident that tests developed and manufactured at GADx will enter clinical validation backed by rigorous evaluation to ensure success.
Regulatory & Clinical Affairs
You need expert guidance through clinical trials and regulatory approval.
- What this covers
To complete the development of your diagnostic test, you can rely on our clinical affairs team to manage all aspects of your clinical trial from start to finish, through trial design, trial centre management, data evaluation and study reporting. Through our global network we can select the appropriate trial centre, recruit patients, and oversee that the trial is done to exacting standards.
Our regulatory team have the knowledge needed to navigate the regulatory pathway appropriate to your assay and market. We can help you achieve the necessary documentation to succeed in regulatory submission. We have the expertise to design your clinical trial and appropriately evaluate and report outcomes to provide a dossier that is ready for submission. Let GADx take care of your regulatory and clinical affairs needs.
Chemistry & Bioengineering
You need high-performance antibodies and reagents engineered to work.
- What this covers
At GADx, we know that exceptional binding reagents are the foundation of breakthrough assay platforms.
Starting with your antigen, we design immunogens that drive the precise antibody response you need—or enhance your existing reagents for unmatched sensitivity and specificity. Our advanced capabilities include high-throughput kinetic screening and expert selection of antibody pairs to ensure optimal immunoassay performance.
Backed by a highly skilled chemistry team, we specialize in intelligent antibody functionalization for superior diagnostics and therapeutic applications. Whether you’re developing new reagents or elevating your current antibodies, GADx is your partner in achieving next-level innovation.
Ready to Discuss Your Project?
Our team is ready to support your diagnostic development journey. Get in touch to explore how we can help bring your vision to life.
Pioneering Diagnostic Innovation Since 2003
Founded by one of the creators of the Clearblue pregnancy test, GADx combines scientific excellence with proven commercialization expertise. We’re ISO 13485 certified and have delivered innovative diagnostic solutions for clients worldwide—from early-stage startups to global pharmaceutical companies.
Our team has deep experience across lateral flow immunoassays, antibody engineering, bioconjugation chemistry, and regulatory affairs. Whatever stage you’re at in your diagnostic journey, we have the expertise to move you forward.
Our Diagnostic Development Process
We support every stage of diagnostic development, from initial research to launch. Engaging us early, in Phase 0 and Phase I, ensures a strong foundation—helping to refine concepts, assess feasibility, and accelerate progress through later stages.
A proven end-to-end pathway from concept to regulatory-ready diagnostic:
Trusted by Leaders in Diagnostics
It is a pleasure working with GADx on the development of a lateral flow test to discriminate Nipah virus infected from vaccinated pigs. Whilst this has proven to be a challenging project, the GADx team have been able to apply their expertise to troubleshoot and design an assay to overcome the challenges encountered
We spent six months at GADx developing lateral flow assays for FMDV. Their team combined deep technical expertise with a proactive, solution-focused approach, enabling efficient progress and valuable knowledge exchange. We highly value this partnership and strongly recommend GADx as a trusted collaborator in diagnostic assay development.
GADx has supported Presymptom Health since 2021, successfully delivering our multi-site PRECISION clinical trial across the NHS despite challenging COVID conditions. Their professional, responsive, and efficient approach has led us to continue our partnership for the upcoming PRECISION 2.0 trial as we advance toward mainstream clinical use.
The Pirbright Institute’s Avian Influenza and Newcastle Disease Group has a strong, long-term collaboration with GADx. They demonstrate exceptional expertise in developing lateral flow assays for rapid avian influenza detection, with technical excellence and responsiveness that has advanced our translational research from lab to field.
Get In Touch
How can GADx help you get tests to people to take charge of their health?
For sales inquiries please contact: info@globalaccessdx.com
For technical support please contact: technicalsupport@globalaccessdx.com
UK: +44 (0) 1234 780020
Address:
Mologic Ltd
Trading as Global Access Diagnostics (GADx).
Company number 04784437
Building 109 Bedford Technology Park, Thurleigh, Bedford, Bedfordshire, England, MK44 2YA
Latest News
GADx and BBI Solutions Partner to Accelerate Lateral Flow Development
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Reflections on Diagnostics at IPSC 2025
At a glance
Global Access Diagnostics (GADx) is a leading end-to-end developer of rapid immuno-diagnostics for human, veterinary and agricultural applications. Founded in 2003 by one of the creators of the Clearblue pregnancy test, our heritage has been built on pioneering innovative approaches to immunoassay development for infectious diseases and immune inflammatory conditions.
As a trusted contract research organisation specialising in assay design and development, antibody engineering, validation and clinical studies, we are proud of our track record in succeeding with the most demanding of challenges. Our expert knowledge, technology and lateral flow platforms enable us to tailor and transform complex customer requirements into leading-edge diagnostic solutions. GADx collaborates with a global network of leaders across diverse capabilities and skillsets to deliver high performance, robust innovations for our clients.
Working alongside industry partners, academia, and not-for profit organisations, our vision is to reinvest profits into impact -led development programs that deliver rapid diagnostic tests that prioritise pressing unmet health needs.
Success for GADx in supporting partnerships in low- and middle-income countries has led to the development of local manufacturing partnerships able to deliver high-quality and affordable diagnostics to underserved populations.
Start your diagnostic project today
From concept to clinical validation, our team is ready to support your journey. Contact us to discuss your project requirements.