lateral flow assay development
End-to-End Rapid Diagnostic Development and Manufacturing
From assay development and point-of-care platforms to contract manufacturing and commercialization support — we partner with you at every stage.
What We Do
Diagnostic Development Services
Built for Scale
From early feasibility to commercial manufacturing — we provide integrated CDMO support across the full development lifecycle.
- Develop
Turn-Key Assay Development
End-to-end assay development support from concept and feasibility through optimization, validation, and commercialization readiness.Learn More - Validate
Clinical & Regulatory Support
Support for verification, validation planning, and technical documentation to help move diagnostic products toward market.Learn More - Launch
Point-of-Care Platform Solutions
Turn-key support for point-of-care diagnostic platforms, helping teams move from early concept to launch-ready execution.Learn More - Manufacture
Contract Manufacturing
ISO 13485 contract manufacturing in the U.S. and Mexico for pilot builds, production transfer, and commercial manufacturing.Learn More - Advise
Diagnostics Consulting
Industry-leading consulting backed by decades of diagnostics experience, from reagent sourcing and product design to market fit and facilities guidance.Learn More
How We Work
A Repeatable System for Every Project
Our structured development process reduces risk, accelerates timelines, and gives your team full visibility at every stage.
- 1Design
Goals & Constraints
Define project objectives, target use case, technical requirements, and key risk points. - 2Assess
Feasibility & Approach
Evaluate assay approach, materials selection, and technical feasibility before committing resources. - 3Develop
Optimization & Prototyping
Iterative assay development, prototype refinement, and performance benchmarking against design targets. - 4Validate
Verification & Validation
Structured verification and validation planning with full documentation support for regulatory readiness. - 5Scale
Transfer & Manufacturing
Technology transfer to production, process refinement, and pilot manufacturing at ISO 13485 facilities. - 6Launch
Commercial Production
Full-scale manufacturing, QA documentation, and ongoing production support for commercial launch.
Our Differentiator
One team. One timeline.
Zero handoff risk.
Why Palladium
Built Different.
We're not a generalist CDMO. We're diagnostics specialists with a fully integrated model — built to move fast, reduce cost, and deliver.
40+ Years of Experience
Our leadership team brings over 4 decades of diagnostics expertise across assay development, manufacturing, and commercialization.Broad Application Expertise
Medical, veterinary, food safety, and industrial — we've developed and validated assays across all major diagnostic markets.Integrated CDMO Model
One partner from feasibility through commercial production. No handoff risk, no lost institutional knowledge, no gaps.Lower Costs, Faster Delivery
Dual U.S. and Mexico facilities with local materials sourcing reduce project costs and improve delivery timelines significantly.
What We Cover
Capabilities & Application
Deep specialization across the full diagnostics development stack, serving multiple markets.
Core Capabilities
- Lateral flow assay development & optimization
- Immunoassay & rapid test design
- Strip design, membrane & conjugates
- Verification & validation planning
- Tech transfer & scale-up
- ISO 13485 contract manufacturing
- QC development & documentation
- Regulatory strategy
Markets & Applications
- Human in vitro diagnostics (IVD)
- Point-of-care & rapid testing
- Veterinary diagnostics
- Food safety & environmental
- Industrial & occupational health
- Infectious disease detection
- Drug of abuse & toxicology
- OEM assay development
Who We Serve
Built for Teams at Every Stage
Whether you're launching a first assay or scaling to commercial production, we have the experience and infrastructure to support your project.
Startups
Innovators & Early-Stage Teams
Concept-stage companies and startups building their first rapid diagnostic product. We help you de-risk development and move efficiently toward a manufacturable assay.
IVD Manufacturers
Established Diagnostics Companies
Larger IVD companies looking for specialized development support, capacity expansion, or a manufacturing partner for new product lines.
OEM / Private Label
OEM & Private Label Partners
Companies looking to source, customize, or co-develop rapid test products under their own brand — from design through commercial supply.
Research
Clinical & Research Teams
Academic institutions and clinical research organizations needing rapid assay development support for investigational or point-of-care applications.
Veterinary
Animal Health & Veterinary
Veterinary diagnostics companies developing rapid tests for companion animals, livestock, and wildlife — a core application market for our team.
Specialty Markets
Food Safety & Industrial
Companies in food safety, environmental testing, and industrial diagnostics that need lateral flow or immunoassay-based rapid test development.
Common Questions
Frequently Asked Questions
Answers to common questions about our services, process, and capabilities.
What is included in turn-key assay development?
Our turn-key assay development service covers the full development lifecycle — from initial feasibility and format selection through assay optimization, prototype refinement, and validation planning. We handle reagent sourcing, strip or cassette design, performance testing, and documentation to support your path to manufacturing.
Do you specialize in lateral flow assay development?
Yes — lateral flow assay development is a core specialty of our team. We bring deep expertise in strip design, membrane selection, conjugate development, and performance optimization for lateral flow immunoassays across multiple markets, including human IVD, veterinary, food safety, and industrial applications.
Can you support assay transfer to manufacturing?
Absolutely. Our Assay Transfer & Scale-Up service is specifically designed to bridge the gap between development and production. We support assay transfer from your team or another CDMO, process refinement for manufacturability, and scale-up to pilot or commercial production at our ISO 13485 facilities.
Do you offer on-site evaluations and consultations?
Yes. We work with facilities across the United States to help provide third-party evaluations and consulting.
What diagnostic markets do you support?
We work across a broad range of diagnostic markets including human in vitro diagnostics (IVD), point-of-care testing, veterinary diagnostics, food safety and environmental testing, industrial diagnostics, and drug of abuse testing. Our team has developed and validated assays in all of these application areas.
Resources & Knowledge Base
Insights from the Field
Assay DevelopmentVerification vs Validation in Lateral Flow Immunoassay Development
Verification and validation are often used interchangeably in lateral flow assay development — but they address different questions, require different study designs, and produce different documentation. Running them out of order, or conflating them into a single study, creates gaps in the design history file that surface later. This guide breaks down what each stage…Read More
Assay DevelopmentLateral Flow Assay Development: Process, Phases, and What to Expect
Learn how lateral flow assay development moves from concept to scale-up across each critical stage. This guide breaks down the full process, common reasons projects stall, and what to look for in a development partner.Read More
News & Press ReleasesPalladium Diagnostics Strengthens Leadership Team to Drive Growth and Innovation
Las Cruces, NM – November 12, 2024 – Palladium Diagnostics LLC, a leading provider of rapid diagnostic solutions, is excited to announce the appointment of Daniel Levenson as Vice President of Business Development. This strategic addition to the team will further solidify Palladium Diagnostics’ position as a premier provider of end-to-end integrated services for complete…Read More
Infrastructure & Quality
Real Facilities.
Proven Processes.
ISO 13485 compliant manufacturing facilities in the U.S. and Mexico, purpose-built for diagnostic test development and production.
🇺🇸 United States
Las Cruces, New Mexico
Our primary U.S. development and manufacturing facility, home to our assay development labs, QC testing, and production operations.
Assay Development
Commercial Manufacturing
QC Laboratory
🇲🇽 Mexico
Manufacturing Facility, Mexico
Our Mexico facility enables cost-efficient production with local materials sourcing, reducing manufacturing costs without compromising quality or compliance.
High-Volume Production
Local Materials Sourcing
Cost Optimization
Common Concerns
We've Heard It Before.
Here's the Truth.
Honest answers to the hesitations we hear most from diagnostics teams considering a development or manufacturing partner.
Common concern
"We already have an internal development team."
That’s great — and we work well alongside internal teams. Many of our clients use Palladium to augment capacity, add specialized lateral flow expertise, or accelerate timelines when their internal team is stretched. We’re a partner, not a replacement.
Common concern
"We're not ready for manufacturing yet."
Most clients aren’t when they first reach out — and that’s exactly when we add the most value. Starting the conversation early means better decisions at every stage. We help teams plan for manufacturability from day one, not as an afterthought.
Common concern
"We've had bad experiences with CDMOs before."
We hear this often. The most common issues are scope creep, poor communication, and no clear accountability. Our integrated model and structured process are specifically designed to solve those problems — with one team, one timeline, and full visibility.
Common concern
"We're not sure our project is ready for a partner."
A preliminary conversation costs nothing and often unlocks a lot of clarity. We offer a free feasibility review so you can get expert input on your concept before committing to anything. Most clients say it’s the most valuable hour they spend early in a program.
Let's Discuss Your Project
From early feasibility to commercial manufacturing, we can help.
Whether you're starting with a concept or ready to scale,
Palladium Diagnostics is your partner.
Whether you're starting with a concept or ready to scale,
Palladium Diagnostics is your partner.