Contract Development  
& Manufacturing

Leverage decades of expertise in lateral flow assay development and point-of-care diagnostics.

Supporting Every Stage of IVD Development

Whether you need expert support for a single phase or a complete turnkey solution, DCN Dx becomes an extension of your team. Together, we’ll guide your lateral flow product to market and ensure successful scaling.

“DCN Dx was highly responsive to our needs and understanding regarding external constraints of our project. The scientific team was skillful, flexible, responsive, and provided us with rigorous reporting. It was a great experience to work together, and we look forward to kicking off Phase 2.”
“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.”
“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.”
“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.”

“It has been a great pleasure working with the DCN assay development and manufacturing teams over the past five years. We have found both teams to be knowledgeable, experienced, supportive, hardworking, talented, resourceful, and dedicated groups who have helped us to complete several challenging projects.”

“From our very first conversation, DCN Dx actually engaged with the complexity of our platform instead of trying to squeeze it into a generic diagnostic template. We’re building a very novel precision oncology technology at the intersection of LDTs, IVDs, and potential breakthrough designation, and DCN Dx has been able to translate that ambiguity into a concrete, thoughtful regulatory strategy while being honest about what is known, what is uncertain, and what our real options are.”

CDMO Services

Contract Assay Development

01

From concept design to reagent selection and prototyping, we provide comprehensive support, ensuring seamless integration and scalability.

Consumable & Cassette Design

02

We engineer custom consumables for lateral flow and other diagnostics, prioritizing assay needs, human factors, validation, and scalable production.

Custom
Readers

03

Save time and resources with our customizable minDxR reader, or ensure your assay integrates with any commercially available reader.

Contract
Manufacturing

04

Scalable manufacturing solutions for validation and clinical trials, through commercial launch, backed by ISO-certified, environmentally controlled facilities.

Clinical Validation
& Regulatory

05

Expert guidance through clinical validation, trials, and regulatory submission, setting the stage for approvals.

Consulting

06

With decades of CDMO experience, we deliver tailored solutions that help you launch faster, more efficiently, and more profitably.

Meet With Our Experts

Our contract assay development team is here to make your project a success.

Our Expertise

Our team delivers innovative solutions across multiple diagnostic platforms—with a special focus on  
lateral flow technology—optimizing performance and usability for any market segment.

.01

A broad range of diagnostic platforms, including lateral flow, flow-through, molecular biology, ELISA, and microfluidics

.02

Qualitative, quantitative, or semi-quantitative assays along with a variety of visual and fluorescent label options

.03

Multiplexing proficiency, including multiple assays per strip and multiple strips per device

.04

Versatile and capable of working with a variety of labels, analytes, and sample matrices across all market segments

.05

Reader and instrument platform integration and customization

.06

Cost-effective design via DFM

.07

POU instruments and consumables

.08

Specialization in imaging

.09

Solutions for field or at-home use

.10

User-centric design for CLIA-waived devices

.11

Customizable core reader systems

CDMO Statistics Hero

DCN Dx by the Numbers

650

+
Completed Client Programs

450

+
Different Assays

300

Organizations
About-Team-Hero-(2)
experts on your side

How can DCN Dx support your IVD goals? Reach out to our team and get expert answers at every turn.

About-Team-Hero-(2)

Insights That Elevate Your Product

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Next Steps

Let’s Get This Project Started.

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Get in touch

3193 Lionshead Ave
Suite 200
Carlsbad, CA 92010
USA

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