DCN Dx

What DCN Dx does

DCN Dx (legally Diagnostic Consulting Network, LLC) is a Carlsbad, California-based contract development and manufacturing organization (CDMO) and contract research organization (CRO) specializing in lateral flow immunoassay diagnostics and broader in vitro diagnostic (IVD) product development. Founded circa 2005-2006, the company serves IVD developers and manufacturers across human infectious disease, oncology, veterinary, and molecular diagnostic segments, offering end-to-end services spanning contract assay development, consumable and cassette design, custom reader solutions (miniDxR platform), contract manufacturing, aseptic filling, reagent lyophilization, regulatory affairs, clinical trial management, biostatistics, data management, and consulting. Operations are anchored in a 35,000+ sq. ft. purpose-built, ISO 13485:2016- and ISO 9001:2015-certified facility featuring a 6,626 sq. ft. BSL-2 development lab, ISO Class 8 aseptic room, dry room, formulation and microbiology rooms, and an engineering workshop with SLA capability.

The company employs 100+ full-time staff and operates a sales-led go-to-market targeting diagnostic developers through direct enterprise engagement, industry conferences (MEDICA, AMP, IDWeek, ADLM, NextGen Dx, Precision Med Tri-Conference), and a thought leadership content program including the Expert Insights podcast, technical whitepapers, and the Advanced Lateral Flow Conference (ALFC) it organizes. Revenue is derived primarily from project-based professional services — CDMO contracts, CRO clinical research, biospecimen collections, and regulatory consulting — with secondary revenue from diagnostic product sales and the Basic Lateral Flow Training (BLFT) course priced at $3,900 (early bird) and $4,900 (regular). Customer logos span large enterprises (Cepheid, Wondfo USA, SRI International) and diagnostic startups (Mainz Biomed, Scout, Gravidas Diagnostics, Viro Research, E25BIO, Mapp Biopharmaceutical, Abingdon), with the company claiming "hundreds of programs and clients" cumulatively.

DCN Dx received a growth investment from Martis Capital in November 2020 and executed three acquisitions between June 2021 and April 2022 — PortaScience (point-of-care diagnostics), IVD Vision (custom reader engineering, software, optical/mechanical/circuit design), and Biomed Diagnostics (veterinary and human microbiological testing) — broadening its lateral flow specialization into adjacent diagnostic categories and productized offerings under retained brands (PortaCheck, miniDxR, Biomed Diagnostics, IVD Vision). The company is led by CEO Charlie Mamrak with Patrick Vaughan, Ph.D. (former VP R&D at Trinity Biotech) as COO, Mitzi Rettinger as Chief Revenue Officer, John L. Tonkinson, Ph.D. as Chief Business Development Officer, and Brendan O'Farrell as President and Founding Partner. The board was reinforced with the appointment of former Meridian Biosciences CEO Jack Kenny. In January 2026 the company launched a new prospective biospecimen collections service, extending the platform upstream into IRB-managed specimen acquisition for IVD validation studies.

Name

DCN Dx

Legal name

Diagnostic Consulting Network, LLC

Website

https://dcndx.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

51–100 employees

Short description

DCN Dx is a Carlsbad, California-based CDMO and CRO specializing in lateral flow immunoassay and broader IVD development. It serves diagnostic developers with integrated assay design, custom readers, contract manufacturing, regulatory affairs, and clinical research services from a 35,000+ sq. ft. ISO 13485-certified facility.

Ownership category

akta.pro rank

Product category

IVD Contract Development & Manufacturing Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK)

Keywords

• Lateral flow diagnostics
• Contract development manufacturing
• Clinical research services
• In vitro diagnostics
• Biospecimen collections

Headquarters

HQ city

Carlsbad

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Development & Manufacturing (CDMO): Full-service immunoassay CDMO providing assay development, consumable/cassette design, custom readers, contract manufacturing, aseptic filling, and reagent lyophilization services for lateral flow and other IVD formats
2. Clinical Research Organization (CRO) Services: IVD clinical trial planning, execution and oversight including clinical operations, data management, biostatistics, regulatory affairs, trial management, site development, and consulting services
3. Biospecimen Collections Service: Prospective biospecimen collections for analytical validation, clinical performance studies, CLIA waiver flex studies, supporting various specimen types including whole blood, saliva, tissue, nasal swabs, stool, urine, and plasma/serum
4. Training Courses: Basic Lateral Flow Training (BLFT) courses conducted at Carlsbad facility, providing hands-on education in lateral flow assay development
5. Product Sales: Diagnostic products and consumables available through e-commerce store

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

DCN Dx is an immunoassay Contract Development & Manufacturing Organization (CDMO) and in vitro diagnostic (IVD) Contract Research Organization (CRO) that provides end-to-end services for lateral flow and point-of-care diagnostic developers. The company offers contract assay development, consumable and cassette design, custom reader development, contract manufacturing (including aseptic filling and reagent lyophilization), clinical trial management, regulatory affairs support, prospective biospecimen collections, and Basic Lateral Flow Training courses.

Product overview

DCN Dx is an immunoassay CDMO (Contract Development & Manufacturing Organization) and IVD CRO (Clinical Research Organization) providing integrated services for lateral flow and point-of-care diagnostics development. The company operates a unified platform combining CDMO services (contract assay development, consumable/cassette design, custom readers, contract manufacturing, aseptic filling, reagent lyophilization) with CRO services (trial management, site development, biostatistics, data management, regulatory affairs). Supporting offerings include a prospective biospecimen collections service, regulatory affairs consulting, and the Basic Lateral Flow Training (BLFT) course. The company also maintains acquired brands including PortaCheck, Biomed Diagnostics, and IVD Vision, and offers the miniDxR custom reader platform.

Differentiator

Problem solved

Functional benefit

Brands

• PortaCheck: A DCN Dx brand offering diagnostic devices for subclinical mastitis detection in veterinary diagnostics.
• miniDxR

Products and services

• Contract Development & Manufacturing (CDMO) Services
• Clinical Research Organization (CRO) Services
• Prospective Biospecimen Collections Service
• Basic Lateral Flow Training (BLFT)
• miniDxR Custom Reader Platform

Quantifiable outcome

• Supported hundreds of IVD programs and clients across various diagnostic modalities
• +1 more outcomes

Named customers7 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Eleven partnerships are on record, tiered strategic and core.

• BIOASTERstrategicStrategic or Co-development Partner · 30 August 2023Collaboration for the development of multiplex rapid diagnostics for neglected tropical diseases affecting millions globally.
• Mapp BiopharmaceuticalstrategicStrategic or Co-development Partner · 1 February 2023Subcontract for Ebola detection diagnostic development.
• Biomed DiagnosticscoreOthers · 25 April 2022Acquisition completed: Microbiologics business focused on microbiological testing products for detecting infectious microorganisms in human and veterinary markets.
• Mainz BiomedcoreStrategic or Co-development Partner · 25 January 2022Partnership for clinical studies supporting Mainz Biomed's colorectal cancer diagnostic product development. DCN Dx providing clinical research services.
• IVD Vision, Inc.coreOthers · 30 June 2021Acquisition completed: Developer of diagnostic systems and devices expanding engineering services and product portfolio with capabilities in custom reader solutions, software development, optical, mechanical, and circuit design for point-of-care diagnostics.
• PortaSciencecoreOthers · 17 June 2021Acquisition of point-of-care diagnostics development company PortaScience.
• AbingdonstrategicStrategic or Co-development Partner · 2 April 2020Partnership on commercialization of Abingdon APPDX M-Health Technology.
• Qiagen Lake ConstancecoreGTM or Marketing Partner · 30 October 2019Collaboration on Rapid Testing Innovation Award, co-sponsored by DCN Dx and Qiagen Lake Constance to recognize innovation in rapid point-of-care diagnostics.
• E25BIOstrategicStrategic or Co-development Partner · 25 September 2018Partnership for development of an in vitro diagnostic for early detection of infectious diseases.
• SRI InternationalcoreStrategic or Co-development PartnerSuccessful partnership on three U.S. government-funded IVD medical device projects. DCN Dx served as innovative and responsive collaborator, prototyping complex assays and advising on appropriate analyzers.
• Wondfo USAcoreStrategic or Co-development PartnerDCN Dx clinical research supported Wondfo's FDA EUA authorization for WELLlife COVID-19/Influenza A&B Test.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Trinity Biotech: Ireland-based IVD developer and manufacturer with a focus on clinical laboratory and point-of-care diagnostics, including lateral flow and immunoassay products. Highly comparable given DCN Dx COO Patrick Vaughan's prior tenure as VP of R&D at Trinity Biotech.
• Meridian Bioscience: IVD developer and contract manufacturer with a portfolio spanning immunoassay, molecular, and lateral flow diagnostics. Comparable as an IVD-focused company offering both proprietary products and life science contract services, recently acquired by Revvity (formerly Eurofins SD).

Broad incumbents

• Eurofins Scientific: Global leader in bioanalytical testing and IVD services, including clinical diagnostics, CDMO, and CRO capabilities. Provides a much broader service portfolio than DCN Dx but overlaps significantly in IVD clinical research and contract manufacturing.
• Charles River Laboratories: Major global CRO with established IVD and diagnostics services alongside its core biopharma preclinical and clinical offerings. Overlaps with DCN Dx on the IVD clinical research side, though with much broader modality coverage.
• QuidelOrtho: Large IVD manufacturer formed through the merger of Quidel and Ortho Clinical Diagnostics, with a substantial rapid diagnostics / lateral flow franchise. Comparable in lateral flow product portfolio but operates at significantly greater scale as an OEM rather than a CDMO.
• bioMérieux: Global IVD company with strength in microbiology and molecular diagnostics (including the BioFire franchise). Comparable to DCN Dx on the IVD/microbiological testing side, particularly given DCN Dx's acquisition of Biomed Diagnostics.
• Sartorius: Bioprocessing and lab products company with growing IVD manufacturing solutions footprint. Overlaps with DCN Dx on the contract manufacturing / CDMO side, though Sartorius focuses on upstream bioprocess equipment and consumables.
• IQVIA: World's largest CRO with significant diagnostics and device clinical research operations. Competes with DCN Dx for IVD clinical trial programs, particularly larger multi-site studies, but with vastly broader global infrastructure.
• Bio-Techne: Life science tools and diagnostics company with IVD reagent development and GMP manufacturing capabilities. Overlaps with DCN Dx on the assay development and reagent manufacturing side, particularly for lateral flow and immunoassay formats.
• Abbott Rapid Diagnostics: Major lateral flow and rapid diagnostics manufacturer (Binax, Panbio, SD Biosensor partnership) and large IVD contract manufacturing organization. Competes with DCN Dx both as an OEM manufacturer and as an in-house alternative for IVD developers seeking rapid test manufacturing capacity.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/dcn-dx
• Xx.com/DCNDiagnostics
• Facebookfacebook.com/dcndx

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries4 records

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about DCN Dx