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CDMO SERVICES
Lateral Flow Assay Development Services
Expertise in Lateral Flow Assay Development
At DCN Dx, we provide end-to-end support for lateral flow assay (LFA) development, from feasibility and prototyping to scale-up and regulatory approval. Our approach is designed for integration: your assay development strategy connects directly with cassette design, reader integration, and manufacturing solutions. Our multidisciplinary team of scientists, engineers, and regulatory specialists works closely with you to ensure your product meets the highest standards of usability, sensitivity, and manufacturability.
Whether you’re launching a new diagnostic or refining an existing test, DCN Dx delivers tailored, scalable solutions aligned with your needs.
Integrated Capabilities for Lateral Flow Development
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Lateral Flow Assay Development
Custom qualitative, semi-quantitative, and quantitative systems using visual or fluorescent labels, adaptable to reader and non-reader-based formats.
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Material Selection & Conjugation
Informed selection of antibodies, antigens, membranes, and labels. We use proven conjugation techniques to maximize assay performance, backed by decades-long supplier relationships.
.03
Multiplexing & Tough Sample Matrices
We specialize in multiplex assays for simultaneous analyte detection in blood, urine, saliva, and other complex matrices—ensuring high performance in challenging diagnostic environments.
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Reader Integration
Seamless pairing with off-the-shelf or custom readers, including our miniDxR system, for both qualitative and quantitative results.
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Analytical Validation & Regulatory Guidance
Support from early validation through clinical trials and global regulatory approvals (FDA, CE, IVDR, etc.). Also available through our CRO: clinical validation and clinical trial management.
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Scale-Up & Manufacturing
ISO 13485-certified facilities enable efficient transition from prototype to scalable commercial production. Includes support for custom cassette design to ensure form factor alignment with assay and reader requirements.
Tailored Support Across the Full LFA Lifecycle
DCN Dx offers comprehensive support for every phase of LFA development. We tailor our approach to match your technical and regulatory requirements, whether you need full-lifecycle support or targeted assistance. From feasibility through manufacturing and kitting, our team ensures that your project stays aligned with performance, cost, and usability targets.
Our Proven Process
01
Feasibility & Prototyping
We assess your assay’s technical requirements and select optimal materials from trusted suppliers. Our reagent-agnostic approach prioritizes performance, cost-efficiency, and scalability. We handle early assay design, pilot testing, and user/market considerations.
02
Optimization & Performance Verification
We fine-tune for sensitivity, specificity, and reproducibility, validating key parameters such as binding efficiency, stability, and detection limits. The result: assays that are ready for high-performance use and reliable scale-up.
03
Scale-Up & Manufacturing
Our ISO 13485-certified facility ensures a seamless move from small-batch prototyping to large-scale manufacturing, optimizing for consistency and cost control.
04
Validation & Launch
We support analytical and clinical validation and guide you through global regulatory pathways. Our CRO capabilities help streamline trials and launch planning.
Benchmarked Against the Industry’s Top LFA Readers
The customizable miniDxR is designed for point-of-care diagnostics, offering unmatched accuracy and speed.
Next Steps