December 4, 2024
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.