OEM Development of Next Generation Lateral Flow Systems

Re-Defining Lateral Flow

Quantitative Sensitive Cost Effective Connected

DCN is globally recognized as the go-to company for contract

development and commercialization of high performance rapid

assay systems.

The Company

• Founded in 2005

• Located in Carlsbad, CA

• 13,000+ square ft,

• ISO 9001:2008 and EN 13485

Main Lab (Class 10,000 capable cleanroom)

Materials Processing Lab

Dry Room

Services

• Lateral flow, flow through &

microfluidic formats.

• Qualitative or quantitative

• Visual or reader-based

• Single or multiplexed

• Visual or fluorescent labels

We offer a unique combination of comprehensive development services

and strategic business knowledge. We guarantee a level of openness,

commitment to service and technical capability that is unequaled in the

industry.

• Expertise in complete device development:

– Industrial Design

– Fluidics design and prototyping

– Reagent development

– Assay development

– Full program management

– Reader integration

– Manufacturing transfer of complete assay

systems

– Commercialization assistance and

consulting

Assay Development Services

• Experienced with fluorescent, visual (colloidal gold / latex/ cellulose nanobead)

& paramagnetic labels

• From concept to commercialized assay in under 12 months

• ELISA conversion to rapid assay formats in short timeframes

• Reagent sourcing and development

• Rapid prototyping

• Feasibility studies

• Complete development

• Manufacturing transfer

Quickly develop and commercialize rapid assays for any application

• DCN can develop and

commercialize all aspects of a point

of care diagnostics platform, through

our in-house capabilities and our

Network of Affiliates

• Custom design and integration for

high performance assays our

specialty

Cartridge top housing

Desiccant

RF id tag

Cartridge bottom housing

Strip & Assay

Integrated System Design & Development

Engineering Services:

Cartridge & Sample Handling Device Design

Plastic devices determine assay performance in demanding applications

and need to be custom developed for high performance applications.

• DCN’s dedicated internal engineering group develops and integrates

new/novel device designs into programs for clients.

• Our active partnerships with high volume medical product molding companies

guarantee smooth transfer of our designs for production.

• Turnkey solutions: DCN will manage the entire development program your

behalf

Education & Training

• Learn how to develop and manufacture lateral flow

assays

• Customized one-on-one courses held at DCN’s core

facility in Carlsbad, California

• Scheduled on demand

• Duration 3 – 5 days

• Theoretical and practical elements covered

• Bring your reagents and optimize an assay during the

course

• Save many months of costly trial and error while

learning the most up-to-date techniques

Starter Kits

• Everything you need for product development in a kit

• Materials Kits

• Gold Conjugation Kit

• Latex Conjugation Kit

• Cellulose Nanobead Conjugation Kit

DCN UltraGoldTM

• 40nm +/- 10%

• Large lot size

• Every batch undergoes TEM sizing

• Stability >1 year

• Available up to OD 15

• Significantly less expensive than other high quality gold

on the market

Alternative Reagents: Cellulose Nanobeads

• These particles are available in a variety of colors and intensities

• They behave similarly to latex particles but are significantly more intensely

colored

• They exhibit very low CV’s in assay systems evaluated by DCN

NanoActtm Cellulose Nanobeads, manufactured by Asahi Fibers

Corporation (Japan) are available through DCN, and can provide added

sensitivity to visual assays.

Cellulose Nanobeads: Application Support

• DCN provides support to users of the NanoActtm particles

• We can assist you in the development or re-optimization of any assays using

these beads

• DCN also provides Starter Kits, that contain protocols, reagents and materials

that assist in the development of products using this technology

• Enquire for details.

Custom Conjugate Development & Manufacture

• Expertise in covalent conjugations

• Protein / peptide /small molecule –Particle

• Colored, fluorescent or paramagnetic latex, gold,

cellulose nanobead, quantum dots, etc.

• Protein – Protein

• Full optimization process

• Full QC including binding assays where reagents are available

• For diagnostics or separations (magnetic latex)

• Small to full prep scale

Sensitive, not Complex:

DCN Fluorescent Test Visualizer

Low cost, robust fluorescent assay reader for field or lab use

Key Specifications:

• Ultra-low cost

• Robust to environmental conditions (heat and humidity)

• Resistant to drop damage

• Has long life

• Can be set up for a variety of fluorophores

• Can be set up to read either bare strips or cassettes

• Cleanable

• Adaptable to lateral flow or molecular diagnostics

Consulting Services

DCN has over 25 consultants on staff that can provide a wide range of services

related to the point of need diagnostics or detection business:

• Quality system

establishment Device

design

• Facility setup

• Equipment specification

and procurement

• Market evaluation

• Technology evaluation

• Regulatory Affairs

• Project management

• Risk assessment

• Intellectual property

landscaping

• Manufacturing process

development

• Assay troubleshooting

• Medical Diagnostics

• Veterinary Diagnostics

• Agricultural/Environmental

• Food testing

• OTC/Consumer

• Pharmaceutical

• Industrial health and safety

• Biowarfare

• Law

enforcement/Forensics

• Microbiology

• Nucleic acid testing

Markets

•Our market is international and

spread over multiple application

areas.

•Approximately 40% of our

assay development programs

are US-based, 40% are

European and 20% are spread

among Asia and South America

•Over 40 completed

development programs since

2005

Select Clients

Example Programs

Infectious Disease

• Anti HIV 1 / 2 (serum, whole

blood, plasma, saliva)

• HIV p24 Ag (serum, whole

blood, plasema)

• Dengue antigen and antibody

(serum, plasma)

• Hepatitis B (serum, whole

blood, plasma)

Human Biomarkers

• Appendicitis protein marker,

quantitative (serum, plasma)

• Kidney disease panel, quantitative,

multiplexed (serum, plasma)

• hCG, standard, extreme dynamic

range (urine, whole blood)

• Cardiac markers TnI, CKMB,

Myoglobin, FABP, ST2 (serum,

whole blood, plasma)

• Progesterone (tears)

• E1G and PdG quantitative (urine)

• Antibodies for Heparin Induced

Thrombocytopenia, quantitative

(serum, plasma)

Veterinary

• Bovine early pregnancy

marker, quantitative

(urine)

• Equine colitis (feces)

Agricultural and Other

• Alpha amylase, quantitative (wheat)

• GMO protein expression (soybean)

• E coli 0157 (food)

• Drugs of abuse panels (urine)

• Caffeine, quantitative (beverages)

Brendan O’Farrell, PhD.,President,

DCN Diagnostics Inc.,

6354 Corte del Abeto,Carlsbad, CA 92011

Tel: 760-804-3886Mobile: 949-872-8589Email: bofarrell@dcndx.com

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