Diagnostic Development
Consulting across the diagnostic development pathway, from biomarker to validation.
Overview
Diagnostic Development consulting supports teams working through the pathway from an identified biomarker to a validated, usable assay — with particular depth in ELISA-based and rapid diagnostic approaches.
The focus is on realistic, resource-appropriate diagnostic development: assays that can actually be validated and deployed with the resources a team has, not a theoretical best case.
How it works
Biomarker & use-case review
Clarifying the target biomarker and the real-world context the diagnostic needs to work in.
Assay design
Designing or refining the assay format, most often ELISA-based or rapid-test concepts.
Validation planning
A validation plan addressing sensitivity, specificity, and practical deployment constraints.
Implementation support
Support through initial validation runs and interpretation of results.
Benefits
A validation plan built around your actual resources and setting
Fewer late-stage surprises in sensitivity or specificity
Access to biosensor and rapid-diagnostic collaboration networks
Research diagnostics grounded in immunology and biochemistry expertise
Frequently asked questions
Yes, from biomarker identification through to assay design and validation planning.
Yes — reviewing an existing assay for validation readiness is a common engagement.
Yes, including rapid diagnostic concepts suited to point-of-care or field deployment.
Regulatory strategy can be discussed, but formal regulatory submission is outside current scope — ask directly if this applies to you.