OEM Development of Next Generation Lateral Flow Systems

Re-Defining Lateral Flow

Quantitative Sensitive Cost Effective Connected

DCN Diagnostics offers OEM development of complete, high performance rapid assay systems for any application.

Our unique staff of assay development and engineering professionals allows us to bring cross functional teams to the development of your entire rapid diagnostic product, covering;

Reagents

Assay

Engineered components

Reader systems

Packaging

Manufacturing process development

Manufacturing transfer

Delivering the Product, not just the Part

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Desiccant

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Strip & Assay

• Expertise in complete device

development: • 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.

• Industrial Design• Mechanical Engineering • Fluidics design • Prototyping• Reagent development• Assay development• Reader integration• Verification and Validation • Manufacturing transfer of complete assay

systems• Commercialization assistance and consulting

Company

Founded in 2006

Located in Carlsbad, CA

13,000+ square ft, custom designed facility

5000 square ft development lab (class 10,000 capable)

Dry room (<15% relative humidity)

Reel to reel pilot plant for product scale up and validation

Engineering lab and workshop space with SLA capability

Operating ISO 9001:2008 and EN 13485

28 full time employees

26 contracted consulting professionals

Company

Unparalleled experience in contract lateral flow platform development

and manufacturing

A single responsible partner for complete product development and

manufacturing transfer

Complete internal program management capability

ISO 9001:2008 and EN 13485 compliant development process

• Deep knowledge of rapid diagnostic market and regulatory

requirements

• Access to unique IP and technology for use in development programs

• Strategic vision, with a wide range of related consulting disciplines

and a broad network of experienced partners and collaborators

• A clear, customer centric service ethos

• Easy contracting. Fee-for-service approach. You own the product

What DCN Offers

• Medical Diagnostics

• Veterinary Diagnostics

• Agricultural/Environmental

• Food testing

• OTC/Consumer

• Pharmaceutical

• Industrial health and safety

• Biowarfare

• Law enforcement/Forensics

• Microbiology

• Nucleic acid testing

• Approximately 40% of our assay

development programs are US-based,

40% are European and 20% are spread

among Asia and South America

• Hundreds of completed development

programs since 2005

Markets

Select Clients

Services and Products

Experienced with fluorescent, visual (colloidal gold / latex/

cellulose nanobead) & paramagnetic labels

From concept to commercialized assay

ELISA conversion to rapid assay formats in short timeframes

Reagent sourcing and development

Rapid prototyping

Feasibility studies

Complete development

Manufacturing transfer

Access to IP around multiplexed arraying in lateral flow

formats

Quickly develop and commercialize rapid assays for any application

Assay Development Services

DCN has license to the patented SymbolicsTM pixilation technology, which allows for new

approaches to result generation in lateral flow, including:

1. Geometric symbols

2. Alpha -numeric symbols.

3. Multiplexing (spot arrays or other formats)

4. Other advanced design features

Multiplexed Arraying in LFA

Infectious Disease• Anti HIV 1 / 2 (serum, whole blood,

plasma, saliva)• HIV p24 Ag (serum, whole blood,

plasma) and combo• 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)

Example Programs

• DCN can develop and transfer all aspects of

a point of care diagnostic platform

• Custom design and integration for high

performance assays our specialty

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Desiccant

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Cartridge bottom housing

Strip & Assay

Integrated System Design and Development

We deliver the product, not just the part

Plastic devices determine assay performance in demanding applications and need to be

custom developed for high performance applications.

DCN’s engineering group develops and integrates novel device designs for our 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

Engineering Services

Specialties Sample collection devices for any sample: whole blood, saliva,

sweat, tears, urine, environmental samples, plant, soil, water, or food

Sample treatment and delivery devices Cassettes for lateral flow or flow through assays Biohazard containment and ease of use Chips for microfluidic immunoassay or molecular diagnostics Integrated devices for field use for military, agricultural,

veterinary or medical use User centric, CLIA waived diagnostic devices with integrated

functions

Engineering Services

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

Education and Training Services

Everything you need for product development in a kit

Materials Kits

Gold Conjugation Kit

Latex Conjugation Kit

Cellulose Nanobead Conjugation Kit

Starter Kits

• 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

UltraGoldtm – 40nm colloid for LFA

• New highly colored particles for use in high sensitivity lateral flow• 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 only available through DCN, and can provide added sensitivity to visual assays.

Cellulose Nanobeads

Higher Sensitivity in hCG

0 200 400 600 800 1000 12000

50

100

150

200

250

300

350

400

DCN CNB

[p24] pg/ml

mV

Graph shows the CNBs gave a significant increase in sensitivity as compared to the colloidal gold in the p24 antigen assay.

Higher Sensitivity in p24

• Limit of detection for the NanoAct™: 31.25pg/ml • Limit of detection for gold assay: 250pg/ml. • Cutoff: visual grade of 2

Higher Sensitivity in TnI

DCN distributes CNB’s and 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

Cellulose Nanobead Support

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

Custom Conjugates

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

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

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

Consulting Services

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

Contact Us