A pointofcare liver function

1
Whitesides Patterned Paper Diagnostics
Sandy Scott (HBS), Hayat Sindi (GSAS), Jose
Trevejo (BIDMC/HMS), Elizabeth Wesson (HBS)
Technology
Applications
The Power of a Diagnostic Labon a Piece of Paper!
The technology is applicable to a wide range of
diagnostic applications

• The George Whitesides laboratory has developed
  diagnostic devices made from patterned paper
• Patterns direct fluid into segregated areas
  where different analytes are detected
  simultaneously
• Paper printed with polymer channels forms a
  cheap and portable platform for detecting
  biological samples

Blood banks
Livestock
Agriculture
Urban clinics
Potential Applications
Military
First responders
Pollution
Point-of- care
Rural Healthcare
Chronic diseases
Industrialized and Less Industrialized
Countries
Market Priorities
Technology Constraints
Antigen-specific Enzyme test
Drug Monitoring
Initial Application
Technology and IP Patterning Paper

• The test area is primed with chemicals that
  change color when an analyte is present
• The liquid sample (blood, saliva, etc.) is drawn
  through the channels by capillary action when the
  edge of the paper is dipped into the sample
• The target analyte (protein, enzyme, etc.) is
  detected by a change in color
• A patent application has been filed by Harvard
  University and is pending

First Application Liver Function Test

• A point-of-care liver function
• test using a drop of blood
• is an important assay
• that can be implemented
• in a variety of settings
• The assay measures the levels of analytes in
  blood that are related to liver damage
• Aspartate-Aminotransferase
• Alanine-Aminotransferase
• Gamma-Glutamyltransferase
• Alkaline Phosphatase
• The assay can be quantitative
• The paper-based device filters blood and runs
  the assays

blood
Prick finger
Squeeze device
Remove filter
glucose assay
protein assay
Completed Assay

Plasma, filtered blood
Top view
Bottom view
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Patterned Paper Diagnostics
Application of Technology
Value Proposition
Screening for liver toxicity An important
application for patients on drug therapy
Impact

• Industrialized Clinics
• Current testing requires a full blood draw and a
  send out lab
• Our test would allow a rapid assessment of liver
  toxicity in the doctors office at low cost
• Global Health
• Most patients do not have access to liver
  screening due to technical and cost constraints
• Our test would allow safer treatment and expand
  the number of patients treated

• Liver toxicity issues are the primary reason for
  drug recall and withdrawal. Yvonne Dragon, FDA
  Director of Systems Toxicology
• Many patients undergoing treatment in
  less-industrialized nations are not screened
  properly and are at high risk for severe liver
  toxicity

• Drug-induced damage to the liver can cause
  serious illness or even death
• Initial onset of liver damage often goes
  unnoticed by patients
• Screening for liver toxicity is standard practice
  for many drug regimens (in industrialized
  countries)

Screening for Liver Toxicity During Drug Treatment
Least Developed Countries (LDC)
Most Developed Countries (MDC)
Tuberculosis
HIV
Diabetes
Heart Disease

• Over 2.1 million people are being treated for TB
  worldwide
• The primary drugs for treatment cause toxicity
  to the liver in 2-18 of patients
• Monthly screening is recommended as standard
  practice for TB regimens

• Over 39 million people are infected with HIV
  worldwide
• Nevirapine is a standard first-line therapy and
  causes liver toxicity in 8-28 of patients
• Liver toxicity screening is rarely available due
  to costs and technical constraints

• 14.5 million people in the US are on oral
  hypoglycemic therapy
• 500,000 new patients per year are started on oral
  hypoglycemic therapy
• Screening for liver toxicity is recommended for
  all patients initiating oral hypoglycemic therapy

• 27.6 million people in the US require
  cholesterol/lipid therapy
• Statins are the primary treatment for lipid
  abnormalities
• Statins cause liver toxicity in 0.5 - 3 of cases
• Simple and cost effective liver diagnostics could
  increase the safety of these drugs

HIV
Source WHO 2006, UN AIDS, 2004
A rapid, inexpensive, point-of-care solution for
monitoring liver toxicity could increase the
number of patients safely treated for disease
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Patterned Paper Diagnostics
Commercialization Plan
Mission
Timeline
Year 1
Year 2
Year 3

• To use technology to solve global health problems
• Establish a stand-alone company that allows us to
  retain control of the technology and apply to the
  greatest social good
• Profits above a threshold net margin will be
  re-channeled into RD to develop further
  applications of the technology

research
funding
pilot
go to market

• Determine shelf-life of
• product.
• Develop new products

Commercialization

• Approach foundations who have
• experience in medical technology
• in less-industrialized regions
• (e.g., Gates Foundation)

Differential Pricing

• LDC market
• Price at marginal cost
• No gross margin

• MDC market
• Price at 25 discount to
• alternative
• Gross margins 25

• Statin or oral hypoglycemic pilot test
• in managed care network or existing
• clinical trial
• Establish relationships with 3rd party
• medical distributors

99 discount
10

• Industrialized Countries
• Establish relationships with 3rd
• party medical distributors
• Enter statin market first hypo-
• glycemic market second
• Less-Industrialized Countries
• Establish relationships with
• procurement agencies

0.10
Current
Alternative
Profitable business in MDC
Profit through increasing the safety of diabetes
and heart-disease treatments by monitoring liver
Liver testing only the beginning

• Dehydration testing for military and athletes
• Over-the-counter body function monitoring
• Rapid disease diagnosis in rural communities
• Water quality testing

PROFIT
RD
Non-Profit in LDC
Further applications for patterned paper
diagnostics
Increase safe treatment of AIDS and TB through
inexpensive, available liver testing