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.

Case Studies — ORIVISE

CASE STUDIES

How technical uncertainty becomes a clearer decision.

These illustrative examples show how independent technical review can help diagnostics teams assess feasibility, identify hidden development risk and decide what should happen next. Examples are anonymised or fictionalised to protect confidentiality

ILLUSTRATIVE EXAMPLES

Four common technical decision points.

Troubleshooting

Resolving variability in an early-stage immunoassay

Decision point: Can this assay move into structured development, or does the variability need to be resolved first?

An early-stage immunoassay was showing inconsistent performance, poor reproducibility and uncertainty around progression into development.

Outcome: The likely technical contributors were clarified, priority evidence gaps identified and the team had a clearer route to proceed, refine or investigate further.

Service: Troubleshooting & Bioconjugation Strategy

Development Readiness

Before CDMO transfer: is the diagnostic prototype really development-ready?

Decision point: Is the assay ready for CDMO transfer, scale-up or formal development?

A diagnostic prototype appeared promising at bench scale, but specifications, reproducibility evidence, reagent controls and transfer assumptions were not sufficiently defined.

Outcome: The review identified what needed to be addressed before transfer, reducing the risk of costly rework, failed transfer or premature CDMO engagement.

Service: Development-Readiness Assessment

Technical Due Diligence

Can the technology deliver what the pitch promises?

Decision point: Does the data room support the investment case?

A pitch deck presented a strong technical story, but the supporting data needed independent review of assay credibility, reproducibility, evidence quality and hidden technical risk.

Outcome: The review clarified which claims were supported, partly supported or unsupported, and gave investors a sharper set of technical questions before proceeding.

Service: Technical Due Diligence & Investment Review

Grant-Led Translation

From academic biomarker to credible diagnostic development plan

Decision point: Is the science ready for translational funding, spin-out planning or industry engagement?

An academic team had promising biomarker evidence but needed to understand whether the concept could become a credible diagnostic development programme.

Outcome: The technical story was reframed around feasibility, development milestones and evidence needed for funders, TTOs or partners.

Service: Grant-Led Translation Support

Resolving variability in an early-stage immunoassay.

Decision point: Can this assay move into structured development, or does the variability need to be resolved first?

Situation

An early-stage immunoassay showed inconsistent performance across runs and reagent lots. Although the assay produced acceptable signal in some experiments, variability made it difficult to judge whether the feasibility evidence was reliable enough to support progression into structured development.

What was reviewed

Assay architecture, existing performance data, reagent-lot behaviour, control strategy, signal-to-noise, background, blocking conditions and the bioconjugation approach.

What was found

The main issue was not simply assay noise. The review suggested that variability was likely being amplified by reagent and bioconjugation factors, with control samples not fully representing the matrix effects affecting real assay performance.

Outcome

The team gained a clearer view of the likely technical contributors, the evidence gaps that needed to be addressed and the next experiments required before deciding whether to proceed, refine or investigate further.

Relevant service: Troubleshooting & Bioconjugation Strategy.

ADVISORY SCENARIO

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