Arista Biologicals Inc. Denise C. Glascock Sales & Marketing Manager

Arista Biologicals Inc.

Denise C. GlascockSales & Marketing Manager

Background 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 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


History 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


History Cont… Problem

EIAs and ELISAs require a lot of time, sophisticated equipment and highly trained personnel. The Primary Issue was Cost

Solution Membrane Based Assays


History Cont… Specific Immunoadsorption

Dipstick Devices Immunoconcentraion Devices

Flow Through Immunochromatography Devices

Lateral Flow


History Cont… 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


History Cont… Specific

Immunoadsorption/Dipstick Devices In the mid-1970’s Dip-Stick tests were

developed for routine chemistry application.

This technology has been adapted for environmental testing.


History Cont… Immunoconcentration/Flow-Through Devices

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.


History Cont… Immunochromatography/Lateral Flow Devices

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.


Today’s Market

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.


Key Market Drivers

Cost/Labor Reduction Reduced Turn-Around-Time (TAT) Disease Focused Testing Convenience and Simplicity Enhanced Clinical Utility


Rapid Test Device Market Segments

OTC/Home Testing

Professional POC/Remote Site Testing


OTC/Home Testing Market

Pregnancy Drugs Of

Abuse Fertility FOBT


Professional POC Testing

Pregnancy Drugs Of Abuse Infectious Disease FOBT


Future Market Trends

Increased demand for quantitative tests

Growth Market Segments are Infectious Disease, Drugs-of-Abuse, Veterinary Diagnostics and Agricultural Testing


Key IVD Growth Assays (Not in order of projected value)

Drugs-of-Abuse Cancer

Screening Osteoporosis Hepatitis B & C HIV

Diabetes Monitoring

Cholesterol/Lipid Panel

Cardiac Monitoring

Saliva Based Tests


Patents in RTD


Patents; Our Opinion

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


Patents

Patents; Why are they important?

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


Patents

Patents; Where can you find them? 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)


Patents

Patents; Where can you find them? 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


Patents

Patents; What should you do Carefully evaluate the existing patent

literature Early in the process of concept

development, work with your patent attorney


Patents

Patents; Some solutions Seek a license Practice in a country not covered by

the patent Invent around critical issues


Documents

Arista Biologicals Inc. Denise C. Glascock Sales & Marketing Manager