DCN Dx

DCN Dx supports IVD programs across assay development, clinical trials, regulatory work, and manufacturing. It also offers diagnostic development strategy, analytical and clinical performance validation, clinical data services, and device quality support.

IVD Assay and Device Development

• Develop IVD assays from feasibility through optimization, validation, and manufacturing, including lateral-flow and immunoassay formats. Analytical work addresses sensitivity, specificity, reproducibility, binding efficiency, stability, and detection limits.
• Design and prototype assay consumables and cassettes through manufacturing, including DCN Dx's own MICA-200C lateral flow cassettes, built to prevent sample leakage, poor sealing and material incompatibility. Its miniDxR, a customizable lateral flow reader for point-of-care settings, can be tailored to a client's assay, with product and software requirements, risk analysis, verifications and a completed Design History File.

Clinical Evidence and Trial Operations

• Plan and execute prospective, multisite IVD clinical studies, from protocol and informed-consent-form drafting through site selection, activation, monitoring, closeout, and submission-ready evidence. Clinical performance studies are aligned with intended use and the submission pathway.
• Manage clinical trial data, biostatistics, statistical analysis planning, recruitment and prescreening, site contracts, study kitting and supplies, and TMF completeness. Direct biospecimen collections can provide healthy, symptomatic, or adjudicated cohorts, including matched specimens, matrices, or panels aligned to a protocol and intended use.

Regulatory and Quality Readiness

• Support device and IVD regulatory strategy, technical documentation, clinical evaluation reports, conformity assessment, post-market surveillance, and submissions. Work includes FDA pre-submission preparation, 510(k) packages, electronic filings, agency responses, and guidance on IVDR/MDR requirements.
• Design quality systems and risk-management approaches, and perform vendor and facility audits for quality and compliance. Regulatory operations support includes submission handling and ongoing program requirements.

Manufacturing and Development Materials

• Scale and manufacture lateral-flow assays through modular operations supported by ISO compliance standards, and perform sterility testing for aseptically manufactured products to confirm the absence of viable microorganisms.
• Supply assay-development and laboratory materials. DCNovations Lateral Flow Materials Kits provide components for starting work in a laboratory, while the Blood Collection/Separation Materials Kit supports blood collection and red-blood-cell separation.

Best Fit

• IVD and point-of-care diagnostic teams needing assay development, clinical evidence, regulatory support, device design, and manufacturing services across a product program.
• Sponsors seeking coordinated CRO operations, clinical data and statistical support, quality-system consulting, regulatory execution, or diagnostic study materials.