The Development of ProteinRepellant Probes for Immunodiagnostic Assays - PowerPoint PPT Presentation

Title: The Development of ProteinRepellant Probes for Immunodiagnostic Assays


1
Probes for Research Diagnostics
Operating Plan Financials
MSE 273
November 4th, 2006
Dorothea Koh, Robert Hanson, Greg Rieker, Tania
Rojas
2
Presentation Outline

• The Need Our Technology
• Value Chain Market
• Operating Plan
• Financials

3
The Need Sensitive Diagnostics
Sectors involved in Disease Diagnostics
Market for Molecular Diagnostics in 2005 6.5
B Molecular Probes 500M
Sector 1
Sector 2
Hospitals Reference Labs (Disease Diagnostics)
Private, Government Academic Labs (RD)
4
The Need Sensitive Diagnostics
Early Detection is the Holy Grail of
Medicine! -UCSF Doctor

• Test for HIV in blood banks

• More sensitive hepatitis tests to protect blood
  supply

• Monitor effectiveness
• of Prostate cancer treatment

• Test for low concentrations of ß Amyloid
• Diffusible Ligand

New Disease Markers

• Detect Troponin-1 for earlier
• diagnosis of heart failure

5
A Day in the Life of a Patient
Test Results!
Blood is drawn from patient
Blood sample is input into an Immunodiagnostic
System
?
6
How does an Assay work?
Disease-specific antibody
HIV disease marker
Incubate Wash
Particle binds to HIV antigens in patients blood
Incubate
Detect Fluorescence!
Add a Fluorescently-labeled Secondary probe
7
Problem A Sticky Situation
Disease markers are Present in ng/mL!
40 mg/mL
40 mg/mL
More than 10,000 serum proteins in blood!
8
Problem Non-Specific Binding
Disadvantages of Current Methods
1. Bovine Serum Albumin

• Long periods of incubation prior to assay (2-4
  hours)
• Coating cannot achieve 100 reduction in
  background signal

2. Depletion of High Abundant Proteins
Agilent HPLC Affinity Column

• Costly Purification systems (2000)
• Lengthy and Time consuming
• Can only remove 98 of the most high abundant
  proteins
• May deplete target further reduction in
  detection sensitivity!

9
Technology Non-Stick Probes

• ltInsert Description of Technologygt
• Experimental results show a
• 99.45-100 reduction in
• protein adsorption in 40 mg/mL
• of Human Serum Albumin (HSA)
• Unique IP We intend to file a
• provisional patent to protect our idea
• Initial IP search has yielded no similar
• patents

Our Solution
ltInsert picture of Solutiongt
10
Presentation Outline

• The Need Our Technology
• Value Chain Market
• Operating Plan
• Financials

11
Value Chain Overview
STAGE I
Research Labs
Large Diagnostic Companies
No FDA approval required!
Marketing
Money flow
STAGE II (reagent kits)
Reference Labs
Hospitals
FDA approval required for Diagnostic kits!
12
Sizing the Market Stage I

• Stage 1 Molecular Beads Manufacturer
• Market Size 500 M
• Customers Research laboratories and large
  diagnostic companies
• Business Model
• Direct sales to research labs
• Partnerships with diagnostic companies
• Competition
• Big Players (e.g. Invitrogen, Seradyn,
  Polysciences)
• Proxy
• Dynal Biotech, acquired for 406 M by Invitrogen
  in 2005

13
Sizing the Market Stage I

• 2005 molecular diagnostics market 6.5 B
• 7.7, 500 M, are molecular probe diagnostics

14
Value Chain Stage I
Partner and sell directly to Abbott, Bayer,
Roche, etc.
Large Diagnostic Companies
Research Labs
No FDA approval required for raw beads!
15
Value Chain Stage I
AACC leads tradeshows, Publications, Journal
advertisements, Website
Large Diagnostic Companies
Research Labs
No FDA approval required for raw beads!
16
Sizing the Market Stage II

• Stage 2 New Diagnostics Manufacturer
• Market Size 10 Billion
• Business Model
• Licensing to big companies (e.g. Abbott, Roche,
  Bayer)
• Partner with dominant players
• Sell reagent kits directly to hospitals
• Competition
• Existing Diagnostic Manufacturers (e.g. GenProbe,
  Nanosphere, Abbott)
• Proxy
• Igen and chemi-luminescence technology acquired
  by Roche for 1.4 B

17
Presentation Outline

• The Need Our Technology
• Value Chain Market
• Operating Plan
• Financials

18
Operating Plan Stage I
Quarter 1-3
Quarter 3-6
Quarter 7-15
19
Operating Plan Stage I
Quarter 1-3
Quarter 3-6
Quarter 7-15
20
Operating Plan Stage I
Quarter 1-3
Quarter 3-6
Quarter 7-15
21
Presentation Outline

• The Need Our Technology
• Value Chain Market
• Operating Plan
• Financials

22
Financials Assumptions

• 1) Cost Model

List Price (1000 per unit)
Revenue (600 per unit)
COGS 150 per unit
Discounts 400 per unit
Profit SGA rD 450 per unit

• 2) Sales Marketing
• Diagnostic Companies Direct Sales force
• Research Labs Tradeshows, Website,
  Advertisements

• 3) Lab Space
• Molecular Medicine Research Institute(MMRI)

23
Financials Income Statement
Millions
24
Financials Operating Stack
Headcount
12
19
37
55
100
25
Financials Cash Flow
Millions
Month
26
Questions?