When standard panels do not cover your science
Commercial assay panels cover the biomarkers most programmes need, most of the time. But the most interesting questions often sit just outside the catalogue:
Custom assay development closes that gap.
We develop and validate bespoke immunoassays across NULISA™, Simoa® and MSD®, so a programme-specific biomarker can be measured with the same analytical rigour as a catalogue assay, and with a validation report that stands up to the same scrutiny.
WHY SIMOA®
What you gain
Alamar-certified for NULISA custom development
One of only five laboratories worldwide certified by Alamar to develop custom NULISA assays, and the only one in the UK. Alamar award that certification. Holding it is what makes custom NULISA work available here.
Three platforms, one scientific team
NULISA, Simoa and MSD are all in-house, so the biology decides the platform.
Non-standard matrix experience
Custom assay work and difficult matrices usually arrive together. We have developed analytical workflows in interstitial fluid, exhaled breath condensate, dried blood spots and tissue lysates, including work with Ascilion on microneedle-sampled dermal interstitial fluid, and in exhaled breath condensate on a deep-lung sampling device we now own.
Senior scientific ownership
Every project is led end to end by a senior scientist. The person who runs feasibility stays accountable for the delivered data, so nothing is lost at handover.
Validation scaled to intended use
Documentation is written to match what the data is for: research-grade discovery, fit-for-purpose validation, or regulator-ready bioanalysis. A discovery study does not carry regulatory burden it will never use. Work heading for a trial is validated to the depth a trial requires.
Talk to a scientist about your targets
WHY custom assay development
Choose the platform around the biology
The right platform depends on required sensitivity, multiplex breadth, sample volume and what the data is ultimately for.
NULISAqpcr™ custom assays
Best where the target is ultra-low abundance, sample volume is severely limited, or the biology sits below conventional assay sensitivity and single- or low-plex ultra-sensitive measurement is what you need. Particularly relevant for CSF, paediatric samples and interstitial fluid.
Our Alamar certification opens this route.
Simoa Homebrew
Best where femtogram-per-millilitre sensitivity is required, where a long validated and published platform track record matters to reviewers or regulators, where the assay needs to align with existing Simoa workflows, or where a proprietary target needs validated single-plex measurement with absolute quantitation.
MSD U-PLEX®, R-PLEX® and custom multiplex
Best for customisable multiplex panels of up to 10 analytes per well: defined pathways, therapeutic mechanism panels, and workflows aligned to GLP or GCP frameworks where MSD’s regulatory familiarity is an advantage.
We will recommend the platform that fits, including when that means a different one from the one you came in asking about.
development method
Our development method
Development runs in three phases, each ending with a decision point. You review the data and confirm whether to continue before the next phase begins.
Sample testing
Your study samples run on the optimised assay, in duplicate against an eight-point standard curve with controls. Where the programme needs data sooner, this can be added at any stage.
Reporting
HOW IT WORKS
How a project runs with us
Development is phased, quoted phase by phase, and invoiced only on completion of each. Every phase ends with a decision point: you review the data and confirm whether to proceed. You are never funding an open-ended programme, and you can stop at any boundary.
How long the whole thing takes
Three scenarios, and it is usually obvious at feasibility which one you are in.
The main drivers are antibody availability, whether the assay is single-plex or multiplex, how novel the matrix is, and the validation depth your intended use requires. You get a firm timeline at feasibility, before committing to anything.
Validation framework
The method draws on current FDA biomarker bioanalytical method validation guidance and ICH M10, applied on a fit-for-purpose basis according to intended use. Reports are prepared at research-grade, fit-for-purpose or regulator-ready level and include the underlying validation data, statistical analysis, method summary and documented limitations.
What you will need to provide
Purified analyte, if you have it: approximately 10 µg for phase 1, more for later phases
Antibodies, if you are supplying them: around 200 µg each for phase 1 and 500 µg for later phases, unlabelled and free of carrier protein
Matrix samples for prototype and sample testing, typically 150 µL each
A shipping manifest with sample ID, matrix, volume and location
Where custom assay development delivers most
Novel and emerging biomarkers
Targets identified through omics discovery, mechanism-of-action work or recent literature, where commercial assays do not yet exist.
Proprietary biomarkers from drug development
Target engagement markers, pharmacodynamic biomarkers, mechanism-specific readouts and safety biomarkers unique to a sponsor’s programme.
Isoform-specific and post-translationally modified targets
Where measurement must discriminate between specific isoforms, phosphorylation states, cleavage products or other post-translational variants, and a commercial assay measuring total protein would answer the wrong question.
Pathway-focused custom panels
Bespoke multiplex panels built around a specific biological pathway or therapeutic mechanism.
Non-standard matrices
Custom assays in interstitial fluid, exhaled breath condensate, tissue lysates, organoid supernatants, lavage fluid and microvolume paediatric samples. Often delivered as paired matrix and assay validation, because in a novel matrix the two questions cannot be separated.
Rare disease and precision medicine biomarkers
Targets in monogenic disease, biologically defined patient subgroups and ultra-orphan indications, where commercial assay development was never economically viable but the biology still demands measurement.
Why you can trust us to build it
If your biomarker is not in any catalogue, that does not mean you cannot measure it
Tell us about your target. If a custom assay is the right answer, we have the platforms, the expertise and the validated workflows to build it. If it is not, we will say so.