For teams that need an independent view of whether an assay concept is technically credible and ready to progress.

ORIVISE reviews existing data, assay architecture, reagent strategy, performance evidence and development assumptions to identify what is working, what remains uncertain and what needs to be addressed before further investment in development.

What’s assessed

• Assay format and detection strategy

• Reagent and bioconjugation approach

• Early performance data and feasibility evidence

• Technical assumptions and unsupported claims

• Key risks that may affect development, transfer or scale-up

Typical outcomes

• Clear recommendation: proceed, refine or pause

• Feasibility risk summary

• Evidence-gap analysis

• Prioritised next steps

• Stronger technical basis for development, funding or partner discussions

Typical questions we answer

• Is this assay concept technically feasible?

• What evidence is needed before development starts?

• What hidden risks could create rework later?

• Is the current data strong enough to support the next decision?

For teams facing assay variability, reagent instability, weak signal, poor reproducibility or unexplained performance issues.

ORIVISE provides a focused technical deep-dive into assay behaviour, reagent interactions, bioconjugation strategy and experimental design to identify likely root causes and practical routes to improvement.

What’s assessed

• Signal-to-noise and background interference

• Reagent interactions and assay architecture

• Conjugation chemistry, orientation and stability

• Run-to-run or lot-to-lot variability

• Critical parameters affecting assay performance

Typical outcomes

• Root-cause hypothesis for variability or instability

• Identification of critical assay parameters

• Targeted experimental direction

• Reduced iteration through clearer problem definition

• Practical recommendations for assay optimisation

Typical questions we answer

• Why is the assay not reproducible?

• What may be causing high background or poor sensitivity?

• Is the bioconjugation approach contributing to instability?

• What should be tested next, and why?

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

ORIVISE assesses whether the assay, evidence base and technical plan are sufficiently mature to support the next stage of development. The focus is on identifying gaps that could create downstream delay, rework or transfer failure.

What’s assessed

• Robustness and reproducibility evidence

• Reagent scalability and control parameters

• Development assumptions and technical file gaps

• Transfer and scale-up readiness

• Alignment with regulated development expectations

Typical outcomes

• Development-readiness assessment

• Identification of risks to reproducibility and robustness

• Defined technical gaps before transfer or scale-up

• Prioritised actions to improve development readiness

• Clearer path toward formal development planning

Typical questions we answer

• Is the assay ready to move beyond feasibility?

• What should be strengthened before transfer or scale-up?

• What risks could affect reproducibility later?

• What makes this assay development-ready?Description text goes here

For investors, angels, venture partners, innovation funders and strategic partners evaluating early-stage diagnostics or IVD opportunities.

ORIVISE provides independent technical assessment of assay claims, feasibility data, development assumptions and technical risk before capital, partnership resources or further diligence effort is committed.

What’s assessed

• Technical data room materials

• Assay feasibility and evidence quality

• Scientific claims and supporting data

• Reagent, reproducibility and development risks

• Technical assumptions behind the investment case

Typical outcomes

• Independent technical due diligence memo

• Data room red-flag review

• Assessment of technical credibility

• Prioritised questions for founders or management teams

• Clear view of proceed, investigate further or pause

Typical questions we answer

• Are the assay claims technically credible?

• What technical risks are not visible in the pitch deck?

• Does the data room support the investment case?

• What questions should investors ask before proceeding?

For academic labs, biohubs, university spin-outs and translational research teams preparing diagnostic concepts for funding, development or industry engagement.

ORIVISE supports research teams in strengthening the technical and commercial logic behind early diagnostic translation, helping convert promising science into clearer feasibility plans, development milestones and funder-ready technical narratives.

What’s assessed

• Feasibility plan and technical rationale

• Evidence gaps and development assumptions

• Translational work-package structure

• Technical risks for grant or funder review

• Commercial and development-readiness logic

Typical outcomes

• Stronger feasibility and translation narrative

• Clearer technical work packages

• Better-defined development milestones

• Improved readiness for funders, TTOs and industry partners

• Independent technical input for grant-led development plans

Typical questions we answer

• Is the project ready for translational funding?

• What technical gaps may weaken the grant case?

• What milestones will make the programme more credible?

• How can the science be framed for development and partner readiness?

For early-stage diagnostics teams that need senior technical judgement but do not yet require a full-time scientific or R&D leadership role.

ORIVISE provides flexible advisory support across feasibility, assay development, troubleshooting, investor preparation, technical planning and strategic decision-making.

What’s supported

• Regular technical review meetings

• Assay development strategy input

• Independent challenge of technical plans

• Preparation for investor, partner or grant discussions

• Troubleshooting and feasibility decision support

• Scientific leadership input at key milestones

Typical outcomes

• Senior technical judgement on a flexible basis

• Clearer development priorities

• Better-prepared investor or partner discussions

• Earlier identification of technical risk

• Stronger decision-making without full-time overhead

Typical questions we answer

• What technical decisions need senior review?

• How should the assay development plan be prioritised?

• What should be challenged before investor or partner meetings?

• Where could technical risk become commercial risk?