Case Examples From Early‑stage IVD Projects
Orivise supports critical technical decisions in early-stage IVD development.
Examples of how early-stage technical challenges were clarified to enable confident development decisions.
Assessing Feasibility of a Novel IVD Assay to Support Early Development Decisions
Resolving assay variability to enable a confident decision to proceed into development.
Situation
High variability across runs and reagent lots made feasibility conclusions unreliable, despite acceptable signal levels in a sandwich immunoassay.
What we did
Reviewed assay architecture and existing data
Mapped variability across plates, operators, and reagent lots
Assessed conjugation strategy, blocking, and controls
What we found
Variability was primarily driven by bioconjugation strategy and non-representative control samples masking matrix effects.
Outcome
Reduced variability to within acceptable limits, enabling a confident “proceed to development” decision.
Clarifying Feasibility for a Sensitivity-Driven Assay
Defining realistic sensitivity limits and translating ambiguous data into a clear development pathway.
Situation
A diagnostics start-up developing a high-sensitivity assay for a low-abundance biomarker had promising early signal, but no clear view of whether the required LoD and functional sensitivity were realistically achievable.
What we did
Defined analytical performance targets aligned to intended clinical use (LoD, LoQ, precision)
Redesigned feasibility studies using appropriate sample panels
Structured experiments to distinguish true signal from assay noise
What we found
The target sensitivity sat beyond realistic biological and technical limits, while variability from handling and timing was masking true performance.
Outcome
Defined realistic performance targets and enabled a clear “proceed with refinement” decision.
Development Readiness Before Technology Transfer
Identifying critical gaps prior to transfer to prevent costly failure and rework during scale-up.
Situation
A mid-sized company planned to transfer an in-house assay to a development partner but lacked confidence in whether the work was sufficiently robust, reproducible, and documented for scale-up.
What we did
Assessed reproducibility across key parameters and operators
Reviewed documentation, design inputs, and risk analysis against ISO 13485 / IVDR expectations
Identified gaps in stability data and critical parameter definition
What we found
Critical parameters were not fully defined or controlled, and stability data was insufficient to support a reliable transfer.
Outcome
Defined a targeted pre-transfer plan, reducing risk of failure, rejection, and costly rework.
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