Assay Development Services
Rapid, Reliable, and Regulatory-Ready Assay Development Tailored to Your Diagnostic Goals
Rapid Point-of-Care Diagnostics
We specialize in assay development services for rapid point-of-care diagnostics. Whether you’re starting with a concept or refining an existing prototype, our team delivers scientifically rigorous, application-specific assays ready for scale-up and regulatory submission.
With over four decades of combined experience, we’ve developed lateral flow, ELISA, flow-through, and microfluidic assays across human, veterinary, environmental, food safety, and pharmaceutical applications. We act as your CDMO partner – not just a vendor – ensuring every assay we build meets your performance goals, regulatory requirements, and commercial realities.
Our Assay Development Services
We evaluate your target, use case, and sample matrix to create a custom assay plan. Whether qualitative or quantitative, visual or fluorescent, single- or multiplexed – we develop for performance and manufacturability from the start.
From custom nanoparticles to proprietary conjugates, we optimize reagents to improve signal, specificity, and consistency across lots.
Iterative development cycles allow us to rapidly prototype and refine assay formats -minimizing time and cost while validating key design elements.
We run precision studies to optimize signal-to-noise ratio, detection thresholds, and assay stability. Our goal is simple: develop assays that are sensitive, specific, robust, and reproducible.
We design with downstream scalability in mind, ensuring materials, formats, and workflows align with GMP manufacturing and automated production.
Diagnostic Platforms We Support
Lateral Flow Assays (LFA)
Flow-Through Assays
ELISA (Direct, Indirect, Competitive)
Microfluidic Devices
What Sets Us Apart
IVD-Focused Expertise
We don’t generalize, we specialize in assay development for regulated diagnostic markets.
Custom Solutions
Every assay is unique. Our protocols and chemistries are tailored to your biological target, sample matrix, and product vision.
End-to-End Support
From proof-of-concept to transfer to manufacturing, we guide every stage of development.
Regulatory-Ready
Our team understands what it takes to build an assay that can withstand FDA, USDA, or IVDR scrutiny.
Assay Development for Your Market
We design assays for a range of applications. Let’s discuss your specific use case and build the right assay for your needs.
Human
Veterinary
Agriculture
Pharma
Environmental
Food Safety
Biodefense
Need to Transfer an Existing Assay?
Our team can evaluate and optimize pre-existing assays for improved robustness, better manufacturing outcomes, and regulatory compliance.
Whether it’s a lateral flow assay needing reformulation or an ELISA requiring scale-up, we’ll help get you across the finish line.
From Prototype to Product
Partner with Gila Bioscience to develop assays that don’t just work – they work at scale, under pressure, and in the real world.
(833) 710-0912
info@gilabioscience.com