Transcript IVD Market & Rapid Assay Market Overview

Arista Biologicals Inc.
Denise C. Glascock
Sales & Marketing Manager
Background
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Founded in 1993 by Dr. John
Colanduoni
Established originally to provide
biological reagents to diagnostic kit
manufacturers.
Now supplies all necessary components
to produce rapid diagnostic assays as
well as the technology required.
Mission Statement
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Our mission is to make available to our
customers, whether they are in the start-up
phase or established, the highest quality
reagents for the lateral flow industry.
We believe this policy will open the market to
people in underdeveloped countries, and will
help bring them the level of healthcare that is
now only accessible to the more developed
countries.
IVD Market & Rapid Assay
Market Overview
Arista Biologicals Inc.
History
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Immunological interactions have been used
for In-Vitro Diagnostic purposes for many
years
Started with Agglutination Assays
Immunoassays became popular with the
development on EIA and ELISA technology
EIAs and ELISAs are still the backbone of
clinical immunodiagnostics
Arista Biologicals Inc.
History Cont…
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Problem
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EIAs and ELISAs require a lot of time,
sophisticated equipment and highly trained
personnel. The Primary Issue was Cost
Solution
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Membrane Based Assays
Arista Biologicals Inc.
History Cont…
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Specific Immunoadsorption
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Immunoconcentraion Devices
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Dipstick Devices
Flow Through
Immunochromatography Devices
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Lateral Flow
Arista Biologicals Inc.
History Cont…
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In the mid-1970’s initial Immunoassays on
membranes were developed as variations of
Dot Blots. The membrane acted as a solid
phase with a surface area for the
immobilization of one of the reactants.
The primary application was in research, not
clinical diagnostics.
This was the precursor to the
Immunoconcentraion/Flow-Through
Arista Biologicals Inc.
History Cont…
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Specific Immunoadsorption/Dipstick
Devices
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In the mid-1970’s Dip-Stick tests were
developed for routine chemistry
application.
This technology has been adapted for
environmental testing.
Arista Biologicals Inc.
History Cont…
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Immunoconcentration/Flow-Through Devices
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In the early-1980’s membranes were first utilized
in immunoassay devices in a vertical flow-through
configuration that exploited the advantages of
using membrane for more than its ability to act as
a solid phase for immobilization.
This configuration reduced incubation times by a
factor of 10.
Allows for the manufacture of simple, rapid,
disposable immunoassay devices that can be used
in the home or in other remote testing sites.
Still requires multiple steps.
Arista Biologicals Inc.
History Cont…
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Immunochromatography/Lateral Flow Devices
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In the late-1980’s a second generation of immunoassay
devices was developed.
Key to Lateral Flow performance is the manufacture of
large nitrocellulose (LPNC) membranes that promotes
the lateral flow of fluids enabling the application of
various immunoreactants at different locations along a
membrane strip.
Enhanced one-step simple, rapid, disposable
immunoassay devices that can be used in the home or
in other remote testing sites.
Does not require training or experienced personnel.
Can easily be used in the home.
Arista Biologicals Inc.
Today’s Market
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There are more than 250 commercial tests available
for Human Diagnostics and Screening, Veterinary
Diagnostics, Agriculture Testing and Environmental
Screening.
The Asian market is exhibiting the most rapid growth.
There are over 200 manufacturers of Rapid Test
Devices in the world.
Increased competition creating pricing pressure.
Arista Biologicals Inc.
Key Market Drivers
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Cost/Labor Reduction
Reduced Turn-Around-Time (TAT)
Disease Focused Testing
Convenience and Simplicity
Enhanced Clinical Utility
Arista Biologicals Inc.
Rapid Test Device Market
Segments
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OTC/Home Testing
Professional POC/Remote Site
Testing
Arista Biologicals Inc.
OTC/Home Testing Market
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Pregnancy
Drugs Of Abuse
Fertility
FOBT
Arista Biologicals Inc.
Professional POC Testing
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Pregnancy
Drugs Of Abuse
Infectious Disease
FOBT
Arista Biologicals Inc.
Future Market Trends
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Increased demand for quantitative tests
Growth Market Segments are Infectious
Disease, Drugs-of-Abuse, Veterinary
Diagnostics and Agricultural Testing
Arista Biologicals Inc.
Key IVD Growth Assays
(Not in order of projected value)
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Diabetes
Monitoring
Cholesterol/Lipid
Panel
Cardiac
Monitoring
Saliva Based Tests
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Drugs-of-Abuse
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Cancer Screening
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Osteoporosis
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Hepatitis B & C
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HIV
Arista Biologicals Inc.
Patents in RTD
Arista Biologicals Inc.
Patents; Our Opinion
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In no way do we encourage you to
infringe upon the patent rights of other
manufacturers of rapid test devices
You have a responsibility to evaluate
existing patent rights
This is an area in which you must do
your homework
Arista Biologicals Inc.
Patents
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Patents; Why are they important?
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Obviously it is important not to infringe on
other organizations’ patents
The patent literature is one of the best
sources of information for this technology
Arista Biologicals Inc.
Patents
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Patents; Where can you find them?
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The Internet, the PTO site
(Http://www.patents.ibm.com)
Certain data bases, Dialog, a very
extensive cross-referenced data base that
is the best source I know for foreign
patents (Derwent file)
Arista Biologicals Inc.
Patents
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Patents; Where can you find them?
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Care should be taken to search for patents
outside the US
European Patent Office Site
(Http://www.epo.co.at/epo/)
Most country patent offices now have a
web site
Arista Biologicals Inc.
Patents
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Patents; What should you do
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Carefully evaluate the existing patent
literature
Early in the process of concept
development, work with your patent
attorney
Arista Biologicals Inc.
Patents
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Patents; Some solutions
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Seek a license
Practice in a country not covered by the
patent
Invent around critical issues
Arista Biologicals Inc.