March 5, 2015 PoCDx Seminar - Wallace White, Stratos - Development of the Pan...
DCN Company Profile 2015
1. OEM Development of Next Generation Lateral Flow Systems
Re-Defining Lateral Flow
Quantitative Sensitive Cost Effective Connected
2. 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
DeliveringtheProduct,notjustthePart
Cartridge top housing
Desiccant
RF id tag
Cartridge bottom housing
Strip & Assay
3. • 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
4. 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
5. 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
WhatDCNOffers
6. • 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
9. 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
AssayDevelopmentServices
10. 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
MultiplexedArrayinginLFA
11. 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)
ExamplePrograms
12. • DCN can develop and transfer all aspects of
a point of care diagnostic platform
• Custom design and integration for high
performance assays our specialty
Cartridge top housing
Desiccant
RF id tag
Cartridge bottom housing
Strip & Assay
IntegratedSystemDesignand
Development
13. 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
EngineeringServices
14. 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
EngineeringServices
15. 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
EducationandTrainingServices
16. Everything you need for product development in a kit
Materials Kits
Gold Conjugation Kit
Latex Conjugation Kit
Cellulose Nanobead Conjugation Kit
StarterKits
17. • 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 –40nmcolloidforLFA
18. • 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.
CelluloseNanobeads
20. 0
50
100
150
200
250
300
350
400
0 200 400 600 800 1000 1200
mV
[p24] pg/ml
DCN CNB
Graph shows the CNBs gave a significant increase in sensitivity as
compared to the colloidal gold in the p24 antigen assay.
HigherSensitivityinp24
21. • Limit of detection for the NanoAct™: 31.25pg/ml
• Limit of detection for gold assay: 250pg/ml.
• Cutoff: visual grade of 2
HigherSensitivityinTnI
22. 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
CelluloseNanobeadSupport
23. 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
CustomConjugates
24. 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
DCNFluorescentVisualizer
Low cost, robust fluorescent assay reader for field or lab use
25. 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
ConsultingServices
