DCN Dx


DCN Dx provides contract development, manufacturing, and clinical research services for in vitro diagnostics with emphasis on lateral flow assay (LFA) development. Services include assay design and optimization, cassette and reader engineering, antibody labeling and label selection, clinical validation and trial management, regulatory strategy and quality management, prototyping and small-volume manufacturing transfer, and supply of LFA materials and conjugation kits. The organization operates ISO 13485 and ISO 9001 certified facilities in Carlsbad, CA and offers training and conference programs for lateral flow development.

Industries

Biotechnology
Consulting
Education
Health Diagnostics
Biotech & Pharmaceuticals
Pharmaceutical and biotechnology
Biotechnology Research

Nr. of Employees

medium (51-250)

DCN Dx

Carlsbad, California, United States


Products

Blood collection and separation materials kit

Kit of materials for fingerstick blood collection and red blood cell separation suitable for blood-based LFA prototyping and sample collection device development.

Colloidal gold supply and conjugation kits

Formulated colloidal gold and conjugation kits for labeling antibodies or antigens used as visual labels in lateral flow assays.

Cellulose nanobead labels and conjugation kit

Cellulose nanobead labeling materials and conjugation kit for preparing labeled detector reagents intended to improve visual sensitivity and support multiplexing in LFAs.

Lateral flow materials starter kits

Kits containing a curated set of membranes, backing cards, pads and other consumables to accelerate early-stage lateral flow development.

Lateral Flow Materials Kit

Mini version of the materials kit containing components necessary to begin lateral flow assay development work in your own lab.

Lateral Flow Materials Kit (MATL-025)

A comprehensive kit containing various membranes, conjugate pads, sample pads, absorbent pads, backing cards, plastic cassettes, and pouches for lateral flow assay development.

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Services

Integrated services for IVDs including assay development, materials selection, cassette design, reader integration, prototyping and manufacturing transfer under ISO-certified quality systems.

Design and execution of clinical validation studies, trial management, site development, biostatistics, data management and regulatory support for diagnostic validation.

Product-specific regulatory assessments, regulatory planning and commercialization advice for US and EU market entry.

Expertise Areas

  • Lateral flow assay development and optimization
  • Antibody labeling and conjugation chemistry for diagnostics
  • Point-of-care and reader-enabled diagnostic development
  • Clinical trial design and clinical validation for IVDs
  • Show More (6)

Key Technologies

  • Lateral flow immunoassays (LFAs)
  • Multiplex lateral flow architectures
  • Quantitative reader-enabled lateral flow
  • Smartphone-based readout integration
  • Show More (10)

News & Updates

Participation in MEDICA 2025 trade exhibition.

Announcement of dates for hands-on lateral flow training courses.

Discussion of future directions for lateral flow diagnostics including decentralization, digital readers, AI-assisted analysis and regulatory considerations.

Overview of antibody labeling materials and detection modalities for LFAs, including nanoparticle, polymer, magnetic, carbon, fluorescent and enzymatic labels, and considerations for conjugation and instrumented readouts.

Overview of materials, sensitivity improvements, quantitative readouts and IoT/data integration for lateral flow immunoassays.

Announcement of a new prospective biospecimen collections service to support assay development and clinical studies.

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