ATTENTION: ASSAY MANUFACTURERS

Grow your assay sales! Enhance your LFAs with new capabilities.

Pair your assays with the Assaya Intelligent Analyzer universal reader to deliver machine-verified, quantitative results that move beyond positive/negative with results securely stored in the cloud. Expanding markets, improving real-world performance, and increasing customer confidence, sales and adoption.

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WHY PARTNER WITH ASSAYA?

Turn your assays into smarter, quantitative connected solutions

When your lateral flow assays are certified for use with the Assaya iaX Intelligent Analyzer they become more valuable and scalable than standalone rapid tests. Machine-read interpretation, quantitative outputs and instant records, so buyers say “yes” faster.

Increase Your Sales

When certified for use with iaX, your LFAs become precise, quantitative, and cloud-ready — eliminating buyer objections and accelerating sales and adoption.

Quantitative Results

Elevate LFA beyond simple positive/negative. iaX provides a precise Quantifiable Unit (QU) result. Test lines become a precise, reproducible number — no subjective calls.

Less Errors & Higher Confidence

Computer vision reduces human read errors. Machine-read interpretation delivers consistent, objective results across operators and sites.

Cloud Records

LFA machine-read results are encrypted, timestamped, and securely stored in the cloud. Integrates with customer systems such as EHR/LIMS for auditable real-time reporting.

Market Access

Unlock clinics, pharmacy, EMS, field, farm, and industrial markets without building your own reader. iaX certifications span US FDA, IVD-CE, IVDR-EU, ANVISA, and more.

Start Immediately

No need to delay or outlay to build your own hardware. Leverage iaX instead of building and validating a proprietary reader stack.

COMPATIBILITY & QUALITY

iaX-Certified Badge & qualification

After your assays are profiled, and verified to read correctly on iaX devices, we provide digital assets that you can use to promote your iaX certification:

On your website
Product Packaging
In your IFU

We will also designate your assays as iaX-qualified in the Assayverse, so they can be found more easily by prospective customers.

The iaX-Qualified Badge

Your assay is profiled and verified to read correctly on iaX across defined lots and conditions:

Assay profile (geometry, timing, thresholds) mapped to iaX
QC/Invalid detection behaviors defined
Calibration curve (dynamic range; LoD/LoQ mapping) recorded
Change-control & versioning registered (lot/config files)
Catalog listing with use-case notes and data outputs

FROM DISCOVERY TO LISTING

Get your assays iaX-qualified in weeks, not quarters

Qualification and certification can be turned around in short order, subject to availability of your assays and controls. Certification is available in Europe, Taiwan, China, and USA.

Discovery & Scope

Use-cases, matrices, targets, and timeline defined collaboratively with your team

Assay Profiling

Cassette geometry, timing windows, controls, and read behavior mapped on the iaX reader

Calibration & Verification

Thresholds, curve fit, and invalid rules established and validated against your reference data

Pilot & Documentation

IFU language, reader prompts, and training assets prepared for your review and approval

Catalog Listing & Launch

Badge issued, assay published to the iaX library, and co-marketing begins. Typical pilot: 2–6 weeks.

Send me the document

Get the iaX Certification Process documentation and outline emailed to your inbox immediately.

EXACTLY WHAT WE NEED

Inputs we’ll ask from your team

Clear, lightweight checklist to keep momentum. Most manufacturers can provide these within days.

Cassette & line layout: geometry drawing (DXF/SVG/PDF)
IFU read timing: min/target/max; revisit drift/over-read risks
Sample matrices & volume: blood/serum/saliva/urine; water/feed/leaf, etc.
Controls & behavior: control/test lines, invalid states, hook effect notes
Performance data: LoD/LoQ, dynamic range, cross-reactivity highlights
Environmental tolerances: temp/lighting ranges for field use
Labelling/ID: lot/expiry format; optional QR/2D codes for metadata
Data model fields: analyte, unit, range, reference thresholds

BENEFITS FOR TEST KIT DEVELOPERS

Turn your LFA into a connected, quantitative, machine-read diagnostics solution

Reduce variability, add quantitative outputs, and deliver audit-ready cloud records — unlocking new markets and faster adoption paired with the iaX Intelligent Analyzer.

Revenue & Market Access

Access to new buyers & use-cases Unlock EMS, pharmacy, clinic, field, farm, and industrial markets without building your own reader.
Faster purchase cycles Machine-read, cloud-ready tests remove buyer objections around variability and record-keeping.
Bigger deal sizes Bundle tests with the iaX platform (hardware + software) for higher average order value.
Tender eligibility “iaX-Qualified” status helps meet machine-read/traceability requirements in RFPs.

Product Performance & Clinical Value

Consistent interpretation Computer-vision reading reduces operator variability vs human interpreted visual reads.
Quantitative outputs Elevate qualitative strips with numbers clinicians can act on and trend over time.
Built-in QC & invalid detection Automated checks prompt retests and cut false calls/returns
Better real-world performance Standardised optics and read windows improve reproducibility across sites

Data, Integration & Insights

Instant cloud records (AssayaDX) Results auto-sync for dashboards, cohort tracking, and remote review
APIs & exports Easy movement of data to LIMS/EHR/ERP for enterprise adoption
Post-market evidence Aggregated (de-identified) performance data supports publications and label expansions.
Usage analytics Understand adoption by site, assay, and indication to guide inventory and roadmap.

Developer Experience & Speed to Market

Rapid qualification path Assay profiling, timing windows, and threshold mapping to get you live quickly
No hardware investment Leverage iaX instead of building/validating your own proprietary reader stack
SDK & tech support Engineering guidance, test plans, and validation templates to streamline onboarding.
Backwards-compatible updates Firmware/algorithm releases maintain assay support without breaking changes

Partnership & Go-to-Market

Compatibility listing & badge “iaX-Qualified” placement in Assaya’s catalog and marketing materials.
Global reach Tap into Assaya’s network across healthcare, agriculture, aquaculture, food safety, and environment.

COMPATIBILITY & QUALITY

Frequently asked questions regarding iaX Certification for Lateral Flow Assays

Your assay is profiled, and verified to read correctly on iaX across defined lots and conditions.

General / Assay Compatibility

+What does it mean for an LFA to be “iaX-Qualified”?

Your assay has been profiled (geometry, timing windows, thresholds), verified on iaX across defined conditions, configured for QC/invalid rules, and listed as compatible. You receive a versioned config and the right to use the “iaX-Qualified” badge.

+Which LFAs can the iaX read?

Most cassette-style lateral flow tests (single or multiplex) with visible control/test lines. We map your cassette layout and kinetics, then tune optics/algorithms to your IFU.

+Do you support multiplex strips?

Yes. We define each line’s position, read order, and timing behavior, then return individual qualitative/semi-quant/quant outputs per line (as supported by the assay).

+Can iaX provide quantitative results?

Where your assay performance supports calibration (curve fit, linearity, LoD/LoQ), iaX can return quantitative or semi-quant values in your preferred units.

+What happens if we change cassette geometry or chemistry?

We re-profile (fast turn). Changes are tracked via versioned configs so existing customers aren’t disrupted.

Timing, QC & Configuration

+What are “timing windows,” and why do they matter?

They’re the valid read interval(s): earliest safe read (T_min), recommended target (T_target), and latest allowed read (T_max). iaX guides operators (countdowns, prompts) to standardise reads and reduce variability.

+How does iaX handle invalid tests or weak control lines?

Built-in checks verify control presence/strength and development time. If criteria aren’t met by T_max, iaX flags Invalid and prompts a retest per your IFU.

+Can we set custom thresholds or reflex logic?

Yes. Thresholds, gray zones, and reflex prompts (e.g., “repeat,” “confirmatory test,” “collect second sample”) are supported in the assay config.

+How do you manage lot-to-lot variation?

Optional per-lot calibration files tighten consistency. We can pin configs by lot and maintain backward-compatible profiles.

+What environmental ranges are supported (temp/light)?

The reader uses controlled optics, but performance still depends on assay chemistry. We profile under expected ranges and add guard bands to timing/thresholds.

Data & Integration

+Where do results go?

Results are stored in AssayaDX (encrypted at rest/in transit) with timestamps, operator/device IDs, and assay metadata.

+Can we export or integrate with our systems?

Yes. JSON/CSV exports and APIs/webhooks let you push data into LIMS/EHR/ERP or your developer dashboards.

+Who owns the data?

You own your assay configuration and associated performance/validation data. Customer test data is owned by the customer; Assaya is a processor where applicable.

+What about offline sites?

iaX caches results offline and syncs automatically when a connection is restored (Wi-Fi/hotspot/USB options).

+Can we add custom fields to the result payload?

Yes — common fields include sample ID, lot/expiry, site/cohort, operator ID, and matrix. We provide a data spec.

Hardware & Operator Experience

+How big is the iaX? Is it field-ready?

Approx. 11.5 × 9 × 10 cm (W × D × H); compact, countertop-friendly, and battery-capable for field and point-of-care use.

+What does the operator experience look like?

Insert cassette → guided countdown to T_min → auto/on-demand read at T_target → clear result (and “Invalid” if criteria fail) → auto-sync to cloud.

+Can we brand the UI or reports?

Light co-branding is supported (logos/names). Full white-label can be explored under partnership terms.

+How many tests can be run per device per day?

Depends on assay read time and workflow; many sites run continuous single-sample throughput. We can help plan staffing and station setup.

Regulatory & Compliance

+What is iaX’s regulatory status?

iaX is positioned as a Class I IVD device for decentralised diagnostics; actual status/indications vary by region. Always confirm local requirements and your assay’s IFU.

+Will this help with audits or tenders?

Yes — time-stamped, user-attributed records, standardised read windows, and versioned configs support traceability many buyers now require.

+How are firmware/algorithm updates handled?

Signed releases with change notes. You can pin versions per assay/lot and stage updates to avoid disruption.

+Can iaX help us tighten our IFU?

We collaborate on IFU language for machine-read steps (timing, invalid rules, reflex testing) to align field performance with your validated use.

Commercial & Getting Started

+What’s the benefit of becoming iaX-Qualified?

Faster adoption (less variability), quantitative outputs (when supported), instant cloud records, access to new markets (clinic, pharmacy, EMS, field), and co-marketing/listing opportunities.

+Do you offer co-marketing or channel support?

Yes — compatibility listing, “iaX-Qualified” badge use, joint pilots/case studies, and distributor bundles.

+Can we sell our assays bundled with iaX?

Yes — through distributor programs or direct agreements. We’ll align commercial and support models.

+What does the Developer Kit include?

An iaX reader, fixtures for fit checks, sample configs/calibration templates, data spec/SDK examples, and the qualification checklist.

+How long does qualification take?

Typically 2–6 weeks from receipt of materials (geometry, IFU timing, performance data, and test lots), depending on complexity.

+What does it cost?

Pricing depends on scope (single vs multiplex, quantitative workup, number of matrices). We’ll provide a proposal after a short scoping call.

GET YOUR ASSAYS QUALIFIED

Start the conversation

Tell us about your lateral flow assays and target markets. Our qualification team will follow up with the process details and timeline.

iaX Qualification Programme

Get your lateral flow assays iaX-qualified for machine-read, quantitative, cloud-connected results — typically in 2–6 weeks. Unlock new markets and accelerate adoption with the iaX Intelligent Analyzer.