ASSAYA SERVICES
Working with you at every stage of the assay life cycle.
From assay design and qualification through to manufacturing consistency and regulatory approval, Assaya supports the full diagnostics lifecycle, helping partners deliver reliable, quantitative results at scale.
Qualify your rapid tests for accurate, repeatable use on the iaX platform
Design new assays optimised for quantitative, machine-readable diagnostics
Achieve lot-to-lot consistency with iaX-based validation workflows
Strengthen your submission data for multi-market regulatory approval
WHO WE WORK WITH
Partners across the diagnostics lifecycle
Assaya consults and works with organizations designing, manufacturing, validating, and deploying rapid diagnostic assays, supporting accuracy, scalability, and regulatory readiness at every stage.
Manufacturers who want their assays qualified for machine reading, digital interpretation, and scalable deployment on the iaX platform.
Organisations developing new diagnostic assays that require quantitative performance, optical consistency, and machine-read optimisation from the outset.
Companies producing assays for third parties that need manufacturing consistency, lot-to-lot validation, and objective quality control processes.
Organizations preparing assays for approval across regions (e.g. CE-IVD, IVDR, FDA, TGA) that require structured performance data and traceability.
Organisations that fund, govern, or oversee large-scale testing programs and require standardized assays, consistent interpretation, and defensible, auditable data.
Organisations exploring novel diagnostic use cases, emerging assay formats, or large-scale deployments that require expert guidance, validation frameworks, and scalable digital interpretation.
IAX PLATFORM QUALIFICATION FOR YOUR ASSAYS
iaX Assay Qualification and Platform onboarding
We qualify rapid diagnostic tests for accurate, repeatable use with the iaX platform, turning existing assays into digitally verified, quantitative diagnostics.
Assaya works directly with test kit manufacturers and partners to qualify lateral flow assays and dip strip tests for use with the iaX reader and software ecosystem.
The qualification process ensures that each assay:
- Supports digital thresholds, trends, and downstream analytics
- Can be reliably interpreted across operators, sites, and environments
- Produces consistent, quantifiable signal readings
- Is optically compatible with iaX hardware
Once qualified, assays are onboarded into the Assaya ecosystem, enabling:
- Scalable deployment across clinical, agricultural, food, environmental, and industrial settings
- Integration with AssayaDX, APIs, and reporting tools
- Standardized digital interpretation
This allows customers to continue using the tests they already trust, now enhanced with intelligence, traceability, and data integrity.
CUSTOM ASSAY DEVELOPMENT CONSULTING
Custom Lateral Flow Assay Development Consulting
We work with you to support the design and development of custom rapid tests, optimized from the outset for quantitative, machine-readable diagnostics.
For organizations developing proprietary or application-specific assays, Assaya provides consulting and technical guidance throughout the LFA development process.
This includes support for:
- Assay design optimized for optical and quantitative reading
- Signal consistency and dynamic range considerations
- Line geometry, contrast, and background optimization for machine interpretation
- Alignment with iaX hardware capabilities and digital workflows
Typical use cases include:
- Species- or condition-specific veterinary diagnostics (e.g. livestock health)
- Food safety and environmental monitoring
- Industrial or biosecurity applications
- Research or surveillance programs requiring consistent quantification
By designing assays optimized for machine reading from day one, partners can avoid the limitations of subjective visual interpretation and accelerate time to scalable deployment.
MANUFACTURING CONSISTENCY
Assay manufacturing consistency and batch validation
We help manufacturers achieve consistency across production lots—using known concentrations, quantitative controls, and iaX-based validation workflows.
Variability between production lots is one of the biggest challenges in rapid diagnostics. Assaya supports LFA manufacturers with tools and processes to measure, validate, and control assay performance at scale.
Using iaX readers and calibrated reference samples, we help manufacturers:
- Validate signal consistency across lots and batches
- Detect drift, variability, or production anomalies early
- Establish quantitative acceptance criteria
This approach enables:
- Higher confidence in assay performance
- Reduced field variability and customer complaints
- Stronger data to support regulatory submissions
- Alignment between manufacturing output and real-world performance
The result is diagnostics that perform consistently, not just in the lab, but in the field.
REGULATORY & MARKET ACCESS
Regulatory and market access consulting
We assist partners with the technical and data foundations required for regulatory approval across selected markets.
Assaya supports assay developers and manufacturers in preparing for regulatory approval by strengthening the technical, performance, and data integrity aspects of their diagnostics.
Our consulting focuses on:
- Generating objective, quantitative performance data
- Demonstrating repeatability, traceability, and auditability
- Aligning digital workflows with regulatory expectations
- Supporting documentation for submissions across target markets
This service is particularly valuable for companies targeting:
- Multi-market expansion
- Regulated clinical or veterinary environments
- Large-scale institutional or government deployments
The result: accelerated market access with fewer regulatory roadblocks, helping manufacturers move from development to commercial rollout faster and with greater certainty.
START THE CONVERSATION
Let’s talk about your assay, use case, or market goals.
Tell us a little about what you’re working on, and our team will help you understand how Assaya can support qualification, development, or regulatory readiness.
Reach out to discuss how our consulting team can support your assay qualification, development, or market-access goals.