DCN Diagnostics designs and develops rapid assay systems for medical and veterinary diagnostics, bio-defense, agriculture, environmental testing and other market segments. DCN's service offering includes contract assay development, education and training courses in lateral flow technologies, industrial design and mechanical engineering services related to development of related devices for rapid diagnostics. Our specialties include lateral flow, flow through and microfluidic assay formats, and we have developed qualitative, quantitative, visual or fluorescent assay systems. DCN's ISO 9001:228 and EN 13485 compliant quality system is set up to allow us to deliver the full FDA compliant design history file. Our process and unique teams of highly experienced development scientists working alongside our engineering teams allow us to deliver the product, not just the parts. DCN Diagnostics is the sole supplier of cellulose nanobead technology for lateral flow diagnostics outside of Japan and can supply technical consulting and development assistance to companies wishing to develop and manufacture highly sensitive and quantitative lateral flow assays using the NanoAct (tm) beads. Our experience in multiplexing and joint ownership in the Symbolics patents covering aspects of multipex arraying in lateral flow formats allows DCN to assist our clients in creating highly unique and functional assays for any environment or application. DCN also provides our unique UltraGold (tm) colloidal gold for use in lateral flow assays. DCN's 40nm gold colloid is highly controlled, very stable and designed specifically for use in lateral flow and flow through assays.

1. OEM Development of Next Generation Lateral Flow Systems
Re-Defining Lateral Flow
Quantitative Sensitive Cost Effective Connected

2. DCN is globally recognized as the go-to company for contract
development and commercialization of high performance rapid
assay systems.

3. 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

4. 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

5. 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

6. • 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

7. 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

8. 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

9. Starter Kits
• Everything you need for product development in a kit
• Materials Kits
• Gold Conjugation Kit
• Latex Conjugation Kit
• Cellulose Nanobead Conjugation Kit

10. 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

11. 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.

12. 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.

13. 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

14. 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

15. 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

16. • 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

17. Select Clients

18. 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)

19. Brendan O’Farrell, PhD.,
President,
DCN Diagnostics Inc.,
6354 Corte del Abeto,
Carlsbad, CA 92011
Tel: 760-804-3886
Mobile: 949-872-8589
Email: bofarrell@dcndx.com
Contact Us