Cheryl McFarlane, Associate Director of Assay of Development & Validation at Almac Diagnostic Services, kicked off her presentation by stressing the importance of flexibility in biomarker assay development. Almac offers off-the-shelf and fully custom solutions tailored to specific clinical trial needs, including adapting assays as trials progress from early to late phases.
McFarlane and her team are responsible for the development of assays for use in clinical trials and guiding them through to CDx programs. Almac has CAP and CLIA-credited clinical tests and laboratories, and McFarlane works with the company’s clinical testing team to transfer all of the devices that they have been developing for deployment in global clinical trials.
One focus of the talk was on custom assay development and validation. For several of Almac’s clients, there are no existing products that they can use, so, in these cases, Almac can build an assay from scratch. McFarlane argued that this can be particularly useful for those outside of the oncology space for disease areas with unique genes. For example, chronic pain disease areas are seeing an uptake in the adoption of precision medicine-based approaches. Almac’s assays provide faster, smaller, or more sensitive testing. Almac is platform agnostic, ensuring flexible, technically appropriate solutions for each partner.
From a regulatory perspective, it is crucial to align assay development with regulatory strategies like IVDR compliance and quality management systems. McFarlane also noted global accreditation requirements to ensure successful deployment in clinical trials. Several key technical considerations were also pointed out, including sample type selection, reagent sourcing (RUO vs. IVD), control manufacturing, platform choice, and the need for robust analytical validation. These factors must all be tailored to the intended use and trial phase.
Moving to a case study to demonstrate the assay in action, McFarlane explained that her team developed a prototype IVD assay for a Phase II/2B trial in MASH, across 150 global sites. The custom design accounted for gene-specific challenges, and they carefully selected globally registered instruments like QuantStudio 5Dx and developed custom software for robust genotype calling. They validated and deployed the assay across multiple accredited labs around the world to ensure consistent analytical performance. The results were highly promising: 98.9% turnaround and 99.2% valid results from 2,500 samples.
McFarlane left the audience with the following key takeaways: plan ahead and engage early with clinical trial solutions providers to discuss budgets, timelines, risks, and options; adopt solutions appropriate for the trial phase and regulatory strategy; and finally, work closely with partners to work around the complexities of biomarker assay development and deployment.
