Collaborate, Accelerate, Deliver

Contract Development & Manufacturing Regulatory & Clinical Research Services

Overview

The DCN Dx Experience

From early-stage assay development to clinical trials, regulatory support, and manufacturing, we integrate seamlessly into your team to tackle challenges at any stage of IVD development. Our multidisciplinary experts provide comprehensive support tailored to your unique needs, delivering the insights, adaptability, and expertise you need to achieve breakthrough results.

Our Business Units

Contract Development & Manufacturing

Assay development, custom readers, and contract manufacturing.

EXPLORE CDMO

Clinical Research Services
& Regulatory Affairs

Clinical trials, data management, biostatistics, and regulatory affairs.

EXPLORE CLINICAL

Biospecimens

Banked human biospecimens and custom collections matched to your assay and intended-use population.

EXPLORE BIOSPECIMENS

DCNovations Products & LFA Education

Lateral flow materials, development kits, and hands-on training.

PRODUCTS LFA EDUCATION

The Proof is in the Partnership

“We’re thrilled to have engaged with the outstanding clinical research team at DCN Dx. Their remarkable skill in designing and managing clinical trials, particularly for molecular genetic diagnostic tests in development, is invaluable.”

Guido Baechler, CEO, Mainz Biomed

“Our experience with DCN has been nothing short of outstanding. Their deep understanding of diagnostics, especially in the molecular realm, was exactly what we needed. Their team stood out with excellent communication, flexibility, and responsiveness, meeting our needs at every turn.”

Alex Jiao, Ph.D., President & Chief Business Officer, Scout

“As a company led by physicians and entrepreneurs, we found a great development partner in DCN. Our partnership helped to save an immense amount of time, provided high-quality development expertise and data outputs.”

Nirdesh K. Gupta, Ph.D., CEO, Gravidas Diagnostics

“SRI and DCN have successfully partnered on three U.S. government-funded IVD medical device projects. DCN has been an innovative and responsive collaborator, prototyping complex assays and advising on appropriate analyzers.”

Will Brubaker, Sr. Program Manager, SRI International

“We deeply appreciate the strong support and dedication from the entire DCN Dx team. Your expertise and collaborative spirit have been invaluable in reaching this accomplishment. We look forward to continuing our successful partnership in 2025 and beyond.”

Jimmy Chen, General Manager, Wondfo USA

“It was a great pleasure to work with the DCN Dx team on our clinical study. Based on past experience working with other contractors, consultants, and CROs, we believe the success of our study was mainly due to DCN Dx’s knowledge, experience, and effective leadership. From the start, the performance of our clinical study was closely monitored and controlled. DCN Dx was able to find and resolve deficiencies before they became bigger problems.”

Nicholas Vafai, Ph.D., Founder & President, and Abbas Vafai, Ph.D., MBA, Senior Scientific Advisor, Viro Research

Services Aligned to
your Needs

Whether you need end-to-end services, just one stage, or troubleshooting expertise, benefit from a partner laser-focused on helping you achieve your goals.

Let’s discuss your project

Wellness Regulatory Assessment

Is your product a wellness product or a medical device?

Get a product-specific written analysis of how FDA’s current general wellness policy may apply, the likely regulatory path, and whether FDA contact is warranted.

Fixed-fee assessment, credited toward qualifying future work
Product-specific analysis
Current FDA policy considerations
Likely regulatory path
Recommended next steps

Explore the assessment

The DCN Dx
Difference

01

End-to-end expertise

From support at a critical stage of your IVD project to providing a complete turnkey solution, our cross-functional team is here to manage risks and expedite results.

02

Total transparency

We believe in clear guidance and open dialogue at every stage of development. Your intellectual property remains fully yours—free of backend supply agreements or licensing strings, ensuring your control over your innovation.

03

Collaboration That Drives Decisions

Our multidisciplinary scientists and engineers bring decades of specialized expertise to empower your team with the insights needed to make confident, informed decisions.

04

Purpose-built facilities

Our 35,000+ sq. ft. custom-designed facility in Carlsbad, CA has dry room capability, a 6,626 sq. ft. BSL–2 development lab, an engineering lab, an ISO Certified Class 8 Aseptic room, Class 9 Gowning, Formulation and Microbiology rooms, and workshop space with SLA capability. Fully ISO 13485- and ISO 9001-compliant, we’re purpose-built to deliver on your needs.