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about us
Your Partner in IVD Innovation
The IVD Team You Want by Your Side
DCN Dx is a Carlsbad, California-based contract development and manufacturing organization (CDMO) and clinical research organization (CRO) serving the in vitro diagnostics industry. The CDMO specializes in immunoassay development and manufacturing across lateral flow, ELISA, multiplex, and other formats, from early feasibility through commercial-scale production under ISO 13485 and ISO 9001 quality systems. The CRO supports IVD developers across all diagnostic modalities, including molecular, immunoassay, and clinical chemistry, with clinical study design and management, biostatistics, data management, and regulatory affairs services for FDA 510(k), de novo, PMA, and IVDR submissions. DCN Dx also operates a prospective biospecimen collections service, delivering IRB-approved, protocol-aligned specimen procurement for analytical validation, clinical performance studies, and CLIA waiver programs.
What We Do
DCN Dx specializes in lateral flow diagnostics development and manufacturing, and IVD regulatory consulting and clinical research.
CDMO Expertise
01
We develop tailored assay systems, consumables, and instruments for point-of-use applications, specializing in lateral flow assays. Our personalized approach has supported hundreds of successful programs across various markets.
CRO Excellence
02
From clinical trial planning through regulatory approvals, we provide end-to-end support for IVD clinical studies, including operations, data management, biostatistics, and regulatory services.
How We Deliver
Exceptional IVD Solutions
At DCN Dx, every project is backed by a team of specialists dedicated to excellence. From assay development to clinical trial management, our tailored solutions are designed to reduce time to readiness, avoid pitfalls, and ensure seamless execution.
Customized Solutions
01
Every project is unique, and we tailor our services to meet your product’s technical, clinical, and operational requirements, accelerating progress while addressing challenges effectively.
Transparency & Ownership
02
With clear communication and fully transparent processes, you retain full ownership of your intellectual property at every stage, ensuring no hidden agreements or dependencies.
Industries We Support
DCN Dx serves a diverse range of industries, providing tailored diagnostic solutions for:
.01
Diagnostics & Health Technologies
.02
Biotechnology & Pharmaceuticals
.03
Food & Beverage Safety
.04
Biodefense & Security
.05
Agriculture & Animal Health
.06
Environmental Monitoring
.07
Nonprofits & Research Organizations
.08
Academic Institutions
Purpose-Built Facilities for
Unmatched Results
DCN Dx’s 35,000+ sq. ft. custom-designed facility includes a BSL-2 development lab, engineering lab, dry room, aseptic room, and SLA workshop capabilities. Fully ISO certified, our facilities are designed to support every phase of IVD product development.
The DCN Dx
Advantage
DCN Dx uniquely combines the technical rigor of a CDMO with the strategic guidance of a CRO, offering comprehensive support for IVD projects. From early development and design to clinical research, validation, and regulatory submissions, our multidisciplinary team ensures your diagnostic product is technically sound, compliant, and ready for the next phase.
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Ensuring Quality and
Regulatory Excellence
Through strict adherence to regulatory standards and a commitment to exceptional quality, DCN Dx consistently exceeds client expectations. Our proactive approach to identifying and mitigating risks ensures your IVD products meet or surpass all necessary compliance requirements.