What is assay feasibility and why does it matter in IVD development?

Assay feasibility is the systematic assessment of whether an in vitro diagnostic assay can realistically achieve required analytical performance — including sensitivity, specificity and reproducibility — under practical development conditions. Most IVD programmes that stall do so not because the science lacks promise, but because feasibility assumptions were not tested against a clear decision framework early enough.

Why is my immunoassay not reproducible or showing high variability?

Immunoassay variability is usually driven by underlying system instability. The most common root causes are inconsistent bioconjugation — where antibody-particle attachment degrades between batches — reagent instability affecting binding characteristics over time, and poorly controlled assay conditions including buffer composition, temperature and incubation timing.

What is technical debt in IVD development?

Technical debt in diagnostics arises when assay data is generated without a clear decision framework — accumulating unresolved questions and untested assumptions that compound during scale-up, CDMO transfer or regulatory review. It manifests as unexpected variability, failed transfer or the need to repeat characterisation studies.

What makes an assay development-ready?

An assay is development-ready when it demonstrates stable, reproducible performance across defined conditions and operators, has clearly defined critical parameters, and shows that performance is consistently achievable — not just demonstrated once. The reagent strategy and evidence base must support a clear, costed development plan.

When should I engage an independent IVD consultant?

The highest-impact timing is before investor discussions, grant applications or major development investment — when assay performance is inconsistent, when preparing for CDMO transfer or scale-up, and when independent technical assessment is required by an investor or partner.

How is ORIVISE different from a CRO?

ORIVISE provides independent technical evaluation and decision support — not laboratory execution. Where CROs generate data, ORIVISE focuses on ensuring the right questions are being asked of existing data and that decisions are based on robust technical foundations before resources are committed.

ORIVISE SERVICES

Independent technical advisory for diagnostics decision points.

ORIVISE helps diagnostics founders, R&D teams, investors and innovation partners assess technical evidence, expose development risk and decide what should happen next.

Core advisory services.

01

Assay Feasibility & Technical Risk Review

For early-stage diagnostics teams that need to know whether the science, assay architecture and supporting evidence are strong enough to progress.

Covers: feasibility evidence, assay format, reagent strategy, technical assumptions, unsupported claims and priority risks.

02

Troubleshooting & Bioconjugation Strategy

For teams facing variability, weak signal, high background, poor reproducibility or reagent instability.

Covers: assay performance issues, reagent behaviour, conjugation chemistry, surface interactions, signal-to-noise and likely root causes.

03

Development-Readiness Assessment

For teams preparing to move from feasibility into structured development, transfer, scale-up or partner engagement.

Covers: robustness, reproducibility, reagent control, transfer risk, development assumptions and readiness gaps.

04

Technical Due Diligence & Investment Review

For investors, funders, venture partners, TTOs and strategic partners evaluating diagnostic opportunities.

Covers: pitch decks, data rooms, evidence quality, technical claims, assay credibility, reproducibility risk and hidden technical debt.

Additional advisory support.

Grant-Led Translation Support

For academic groups, spin-outs and translational teams preparing diagnostic concepts for funding, partner engagement or commercialisation.

Fractional R&D Advisory

Senior diagnostics R&D judgement on a flexible basis for teams that need strategic technical input without a full-time appointment.

R&D Performance & Capability Support

Support for R&D prioritisation, workflow improvement, team capability and better development decision-making.

HOW ORIVISE WORKS

A structured framework for technical decisions.

01

Define

Clarify the technical question and the decision the evidence must support.

02

Prove

Assess existing data, assay architecture, reagent strategy and performance claims.

03

Develop

Identify risks and gaps that could create rework or failed transfer at a later stage.

04

Advance

Recommend prioritised actions with clear conditions for progression, refinement or pause.

Supported Partly Supported Unsupported Not Assessed

WHEN TO ENGAGE

Engage at the moments where technical uncertainty becomes commercial risk.

Early feasibility

Before investor discussions, grants or major development investment

Build a credible, defensible technical story before claiming readiness.

Technical due diligence

During investment, acquisition, grant or partner evaluation

Identify hidden technical debt before capital is committed.

Development readiness

3–6 months before CDMO transfer, scale-up or formal development

Prevent costly transfer failures and establish what needs addressing first.

Critical troubleshooting

When assay performance issues stall programme progress

Unblock development with structured root-cause analysis.

Not sure which service fits?

Start with a 30-minute discovery call focused on the decision you are trying to make.

Book a discovery call →