Molecular diagnostics consulting.
Advisory engagements on molecular diagnostic strategy — technology selection, pipeline planning, and investment-grade technical review.
What we mean by molecular diagnostics consulting.
This is strategic work, not hands-on lab work. The questions we help teams answer are the ones that decide whether a programme is worth running at all: which platform is appropriate for the target, which target is appropriate for the market, which regulatory pathway is realistic, and what evidence package the endgame requires.
Outputs are written — assessments, plans, decision memos — not lab data. The point of a consulting engagement is to give a decision-maker a defensible basis for committing or de-committing capital. Anyone who promises certainty in this space is selling certainty, not strategy.
We bring our own programme’s vantage to client work: we run a CRISPR diagnostic ourselves, we are inside the IVDR process, and we know which decisions get expensive when they get postponed.
Who we advise.
First-time entrants
Companies entering molecular diagnostics for the first time and choosing a platform, before significant capital is committed.
Established teams expanding
Existing diagnostics groups evaluating whether to add a new modality — CRISPR, isothermal amplification, microfluidics — to the platform.
Investors and corp-dev
Investment teams running technical diligence on a diagnostic asset and needing an independent read on the underlying science.
How a consulting engagement runs.
Consulting engagements are scoped tightly. Before any work begins we agree the question, the artifacts you need, and the timeline. Most engagements run on a fixed-fee basis against a written deliverable; if mid-engagement findings change what makes sense to do next, we revise the scope in writing rather than absorbing it silently.
Other ways we partner.
CRISPR assay development
Design and optimisation of Cas-based detection assays for nucleic-acid targets in clinical and research settings.
Clinical validation support
Study design, partner sourcing, and analytical-to-clinical performance evaluation for diagnostic candidates.
Regulatory strategy
IVDR-aligned planning for CE marking pathways, technical-file structuring, and post-market surveillance.
Contract research
Targeted laboratory work for biotech and pharmaceutical partners — flexible scope, rigorous documentation.
Global procurement services
Sourcing of medical devices, IVDs, and pharmaceuticals from European supply chains for international partners, with full audit and compliance documentation.
Get an honest read on your diagnostic strategy.
If a strategic question is blocking a programme decision, we’ll help you frame it before you commit.