Global Health Diagnostics – Science or Fiction?

4th IAS Conference on HIV Pathogenesis, Treatment and Prevention

22-25 July 2007 - Sydney, Australia

Dr Penny WilsonDiagnostic Specialist, UK

The Golden Age of Diagnostics

• Diagnostics now a central and integral part of disease management. Driven by the human genome project, trends towards personalised medicine and economics.

• Contribute to:-– Diagnosis, prognosis and predisposition– Treatment selection– Drug monitoring – Assessing treatment efficacy, adverse side

effects and drug resistance

Diagnostic Technologies (1)

• Trends are towards:– Miniaturisation (including POC

devices), greater sensitivity, increased speed, decreased cost

– Multiplexing/microarrays– Possible to sequence the human

genome overnight by 2020 ?– Improved bioinformatic

capabilities• considered the rate limiting

step by informatics companies

Diagnostic Technologies (2)

• Trends are towards:– Novel biomarkers

• Including non-invasive markers (eg VOCs)

– Improved ICT capabilities at reduced cost– Development of technologies by companies

outside the classical Diagnostic arena– Industry-wide trend towards interoperability

• Intellectual property, ROI and securing market share have inhibited this

Mobile Phone companies move to e-health

• Fitness and Lifestyle• Preventative Healthcare• Professional Diagnosis and Therapy

• Cambridge University and the MRC are developing a device to detect cancer and infectious diseases

• The technology utilises thin film transistors

Do these technological advances benefit the developing world or increase the North: South divide?

• Technologies are too costly for the developing world

• Designed for use by trained professionals in modern laboratories

• Third and fourth generation devices may be more cost effective (10 – 20 yrs)

• Devices for self-testing may offer robust solutions (lateral flow)

Commitment to disease futures

“sustained action and coherent, multi-national cooperation to fully mobilize new and existing technical, medical and financial resources in the fight against infectious diseases”

G8 Summit 2002

“improved international surveillance…intensification of scientific research … fulfilment of prior G8 commitments on the major infectious diseases”

G8 Summit 2006

Global Activity

• Global Health• The World Bank• WHO• The Bill & Melinda Gates Foundation• The UK Foresight Programme (2006)• OECD (2003)• Institutes of Medicine, NAS studies (1992-2007)• FIND Diagnostics

Malaria rapid diagnostics manufacturers: 1992

Becton Dickinson

Akers Laboratories International Immuno-Diagnostics

Alldiag. France Kat-Med

AmeriTek MAKROmed

BBInternational Orchid Biomedical Systems

Binax PATH

Cellabs PTY Princeton BioMeditech

Core Diagnostics Ltd. Quorum

Cortez Diagnostics Shin Jin Medics

DiaMed AG SPAN Diagnostics

Dainabot Standard Diagnostics, Inc

Flow Inc. Thailabonline Thailand

Genix Technology Trinity Biotech

Greencross Life Science Vision Biotech (Pty) Ltd

ICT Diagnostics World Diagnostics, Inc

Malaria rapid diagnostics manufacturers: 2002

Components of a Classical Diagnostic (pathogen detection/host response)

• Biomarker• Sample type (and preparation)• Technology for biomarker detection• System for reporting presence of

biomarker• Infrastructure for delivering appropriate

response• THESE COMPONENTS ARE

UNIVERSAL

Test characteristics include

• Sensitivity

• Specificity

• Time to first result

• Through- put

• Requirement for electricity, reagents (including clean water) and auxiliary equipment

• Level of training required to run test

• COST

Annual per capita health care expenditure

0200400600800

1000120014001600

High incomecountries

Low-incomecountries

Africa

Infrastructural Levels

Lab Infrastructure Healthcare setting (personnel)

NoneCommunity or home (pharmacist, family member, healthcare worker)

MinimalHealth clinics in Africa /rural clinics in Latin America & Asia (nurse)

Moderate to Advanced

Hospitals in Africa/urban clinics in Latin America & Asia (nurses, technicians, physicians)

Infrastructural Levels (2)

1 2 3

Electricity and clean water

X Unreliable Dependable

PersonnelNo

trainedMinimal trained

Trained

Lab space XMinimal or

noneDedicated

Cold storage X Occasionally Available

RT control X Rarely Sometimes

Infrastructural Levels (3)

1 2 3

Venipuncture Impossible Unlikely Routine

Sputum processing

Impossible DifficultAcceptable

(not children)

Acceptable time to result

< 1 hour < I hourClinic < 1h

Hospital – not critical

Physician oversight

None None Routine

The Ideal Diagnostic - ASSURED

• Affordable

• Sensitive

• Specific

• User-friendly

• Rapid and Robust

• Equipment -free

• Delivered to those who need it.

Developed by WHO

H207

Quantum leaps will benefit the developing world

Impact of improved HIV test in infants

0

500000

1000000

1500000

2000000

2500000

3000000

3500000

Moder

ate

Min

imal

None

New Dx Infrastructure Requirements

To

tal a

dju

sted

life

yea

rs s

aved

5% ART

50% ART

100% ART

OFFICE OF SCIENCE AND INNOVATION

Foresight Infectious Diseases: preparing for the future

Foresight“Creates challenging visions of the future to inform effective strategies now.”

Infectious Disease Project:

Key Question: How can we use science and technology to improve our capability for detecting, identifying and monitoring infectious diseases in order to improve control?

Ultimate goal: To detect all known and unknown infectious diseases, of plants animals and humans, in ~ 30 years.

OFFICE OF SCIENCE AND INNOVATION

Foresight Infectious Diseases: preparing for the futureUser Challenges

UC1: Novel information technology for the capture, analysis and modelling of data for the early detection of infectious disease events.

UC2: Early detection and characterisation of new or newly resistant/virulent pathogens using genomics and post genomics.

UC3: Taking technology for identification and characterisation of infectious diseases to individuals by designing smart swabs, hand-held or portable devices that analyse fluids.

UC4: High throughput screening for infectious diseases of people, animals and plants using surrogate, non-invasive markers (e.g. electromagnetic radiation, volatiles), for example in airports, containers and livestock markets. 

User Challenge Roadmaps – basic template

Now 5 Near 10 25-3020

Systems

Applications

Technologies

Drivers and trends

Time (Years)

UC3 Roadmap (section) A

p pli c

atio

nsT

echn

olog

ies

“Time”

Standard platforms agreed

Wild animal surveillance defines zoonotic hot-

spots. Lab informs design of screening test

Animal biomarkers for pathogens

Detection of pre-symptomatic

disease and host susceptibility

Novel sequencing/detection

technologies

Devices for increasing numbers of known diseases available. Trend from stand-alone to ICT integrated devices and from professional to non-skilled users

Smart objects

Trend from PCR to robust simpleamplification technologies and systemscapable of functioning in extreme environmental conditions

Devices for novel human diseases

ICT type systems mature enabling full integration of POC devices with global

networks

Devices for all known pathogens available. Output fully integrated into international networks maximising data utility etc

Immune signatures of animal infectious diseases emerging

Immune signatures of human infectious diseases emerging

Sys

tem

s

Roadmap for using handheld/portable devices for the detection, identification and monitoring of infectious diseases in plants, animals and humans (Fig. 1)

Growing market in personal healthcare, driven by devices for management of chronic diseases, general wellbeing and lifestyle

Nanotechnologies, microfluidics, MEMS, developed for other markets allow reduction in sensor size and improved capabilities

Decreasing size and cost of GC-MS - driven by space flight, environmental and homeland security

Driv

ers

and

tren

dsS

yst e

ms

App

licat

ions

Tec

hnol

ogie

s

Animal DIM mainly by

symptoms, not biomarkers

Now Near 10 25-3020

Standard platforms agreed

Wild animal surveillance defines zoonotic hot-spots. Lab informs design of screening test

Animal biomarkers for

pathogens

Detection of pre-symptomatic

disease and host susceptibility

Novel sequencing/detection

technologies

Devices for increasing numbers of known diseases available. Trend from stand-alone to ICT integrated devices and from professional to non-skilled users

Smart objects

POC devices for non-ID applications

eg. SMBG and pregnancy tests

Mobile telephony and pervasive computing allow more rapid networking and greater local data and processing power

Trend from PCR to robust simpleamplification technologies and systemscapable of functioning in extreme environmental conditions

Cheaper microfluidic based biosensor technologies for nucleic acid and protein determination

POC technologies available for

DIM but limited

POC devices emerge for

professional use

Mobile phones measure pulse,

blood pressure etc

Devices for novel human diseases

ICT type systems mature enabling full integration of POC devices with global

networks

Devices for all known pathogens available. Output fully integrated into international networks maximising data utility etc

Immune signatures of human infectious diseases emerging

Immune signatures of animal infectious diseases emerging

Devices linked to networks

Stand-alone devices POC devices

KE

Y

Culture and governance issues SSA China UK

Go

vernan

ce

International + + +++

Regional/supra-national groupings ++ + ++

National ++ ++ +++

Local/provisional ++ +++ +++

Ability to implement measures through legal or coercive measures

++ +++ +

DIM interaction with control mechanisms + ++ +++

Investment in science and technology + ++ +++

Data-sharing culture ++ + +++

So

cial asp

ects Religious and societal beliefs/concerns +++ +++ +++

+ limited influence+++ prominent influence

Greater importanceIn 10 – 25 yrs

In Conclusion

• The concept of Global Health Diagnostics is deeply embedded in science and is certainly not fiction

• Diagnostic tools will provide only part of the solution, their impact will depend on the disease management infrastructure into which they are deployed, including the availability of appropriate therapies.