CDMO Service

Lateral Flow Assay Development Services

Move from assay concept to a development path built for feasibility, transfer, and scale-up. Palladium Diagnostics provides lateral flow assay development services for teams that need to reduce technical risk early and move toward a manufacturable product with more confidence.
What We Support

Lateral Flow Assay Development Services

A stage-based approach built around what actually determines whether a rapid test program succeeds: feasibility grounded in the target matrix, optimization with intended use in mind, and development outputs that hold up when it's time to transfer and scale.
  • Assay Optimization

    Refine assay conditions, performance parameters, and test architecture with intended use in mind — not just early bench success.

  • Reagent & Matrix Strategy

    Assess how antibodies, antigens, conjugates, and sample conditions behave in the target matrix and expected use environment.

  • Verification Planning

    Define the testing strategy and documentation needed to support performance claims and downstream development decisions.

  • Technology Transfer Support

    Build development outputs that actually transfer. By treating handoff planning as a development requirement rather than a post-development task, programs arrive at transfer with fewer gaps to close.

  • Manufacturing Readiness

    Prepare the assay for a more reliable transition into manufacturing by identifying key scale-up variables early — instead of discovering them after the bulk of development work is already complete.

Palladium supports biotech and IVD startups, diagnostic and OEM programs, and NGOs or decentralized testing initiatives that need a CDMO partner for lateral flow assay development, technology transfer, and manufacturing readiness.

Early Engagement Matters

Evaluating a new assay concept or trying to de-risk an existing program?

Schedule a Feasibility Consultation
How Our Program Works

Build with Feasibility, Transfer, and Manufacturing in View

Most projects begin with some combination of the following. If some of these inputs are still being defined, a feasibility discussion can help clarify the right next step.

For a deeper overview of what the full lateral flow assay development process involves, see our process guide.

01

Moving into optimization before feasibility is established

Many programs enter optimization with unresolved feasibility questions — and pay for it later with rework, missed timelines, and weaker data. Palladium evaluates feasibility against actual sample conditions, product goals, and downstream constraints before committing to the next phase.
02

Reagents and matrix conditions evaluated too late

An assay that performs in buffer but breaks down in whole blood or saliva may not be ready for full development. Palladium assesses reagent behavior against the target matrix and expected use conditions from the start — because that is what the product will actually encounter.
03

Technology transfer planning deferred until late in development

When handoff planning is treated as a development requirement — not a post-development cleanup — programs transfer with fewer gaps and scale with fewer surprises. Palladium structures development outputs with transfer and manufacturing execution in mind from the beginning.
04

Scale-up variables discovered after development is complete

When scale-up variables are identified late, they generate rework and delay. Palladium keeps manufacturing readiness in view throughout development — so key variables are defined, not deferred.
05

Documentation gaps that slow decision-making and transfer

Palladium approaches development with documentation and stage-gate outputs in mind — including the kinds of deliverables teams may need to support decision-making, transfer planning, and downstream development work. For regulated or commercialization-bound programs, this matters earlier than most teams expect.
Getting Started

Start with a Feasibility Discussion

Most projects begin with some combination of the following. If some of these inputs are still being defined, a feasibility discussion can help clarify the right next step.

For a deeper overview of what the full lateral flow assay development process involves, see our process guide.

  • A defined target analyte
  • An intended use setting
  • A target matrix
  • Performance goals
  • Existing antibodies, antigens, or preliminary technical data (if available)
The First Conversation

What to Expect from a Feasibility Consultation

A feasibility consultation is designed to help your team make a better next decision. We use it to review your concept, identify key technical risks, and determine the most appropriate next phase for the program.

  • Your assay concept and intended use
  • What is already known and what still needs to be validated
  • Matrix and reagent considerations
  • Likely development risks and key assumptions to test first
  • What an appropriate next-phase scope may look like
Book a Feasibility Consultation
FAQ

Frequently Asked Questions

Most projects begin with some combination of the following. If some of these inputs are still being defined, a feasibility discussion can help clarify the right next step.

Lateral flow assay development services help teams move from an assay concept toward a functional, manufacturable rapid test through feasibility work, optimization, transfer planning, and manufacturing readiness support.

The best time is often before major optimization work begins — especially if target matrix behavior, reagent selection, intended use, or scale-up path are still uncertain. Early engagement reduces the cost of decisions made on incomplete assumptions.

No. Many teams begin with a target, an intended use concept, and some early technical inputs. A feasibility discussion can help define the right path when parts of the program are still taking shape.

Yes. Palladium’s development approach is built with technology transfer and manufacturing readiness in mind — to help reduce downstream handoff risk rather than address it as an afterthought.

Because performance in buffer does not always translate to whole blood, saliva, urine, swab extracts, or other real sample types. Matrix conditions can significantly affect assay behavior and feasibility.

Yes. Programs intended for point-of-care, decentralized, or field-use settings often require additional attention to robustness, usability, and environmental tolerance — factors that need to be considered early in development

Who We Typically Support
Biotech and IVD startups moving from concept toward feasibility
Diagnostic and OEM teams reducing transfer and scale-up risk
NGOs and field-use programs developing assays for real operating environments
Ready to Discuss Feasibility

We Know Where Lateral Flow Programs Go Wrong — and How to Help You Avoid It

If you’re evaluating a new assay concept, trying to de-risk an existing program, or looking for a CDMO partner that builds toward transfer and manufacturing from the start, schedule a feasibility consultation to identify the highest-priority risks and define the right next step.