Global Health Diagnostics Science or Fiction

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Global Health Diagnostics Science or Fiction?
Dr Penny WilsonDiagnostic Specialist, UK

• 4th IAS Conference on HIV Pathogenesis, Treatment
  and Prevention
• 22-25 July 2007 - Sydney, Australia

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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

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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

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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

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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

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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)

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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 surveillanceintensificat
  ion of scientific research fulfilment of prior
  G8 commitments on the major infectious diseases
• G8 Summit 2006

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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

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Malaria rapid diagnostics manufacturers 1992
Becton Dickinson
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Malaria rapid diagnostics manufacturers 2002
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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

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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

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Infrastructural Levels
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Infrastructural Levels (2)
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Infrastructural Levels (3)
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The Ideal Diagnostic - ASSURED

• Affordable
• Sensitive
• Specific
• User-friendly
• Rapid and Robust
• Equipment -free
• Delivered to those who need it.

Developed by WHO
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H207
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Quantum leaps will benefit the developing world
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Impact of improved HIV test in infants
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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.
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User 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.
•  

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User Challenge Roadmaps basic template
Systems
Applications
Technologies
Now
5 Near
10
25-30
20
Time (Years)
25
UC3 Roadmap (section)
ICT type systems mature enabling full integration
of POC devices with global networks
Wild animal surveillance defines zoonotic
hot-spots. Lab informs design of screening test
Standard platforms agreed
Systems
Devices for novel human diseases
Animal biomarkers for pathogens
Smart objects
Devices for all known pathogens available. Output
fully integrated into international networks
maximising data utility etc
Detection of pre-symptomatic disease and host
susceptibility
Applications
Devices for increasing numbers of known diseases
available. Trend from stand-alone to ICT
integrated devices and from professional to
non-skilled users
Immune signatures of animal infectious diseases
emerging
Immune signatures of human infectious diseases
emerging
Trend from PCR to robust simple amplification
technologies and systems capable of functioning
in extreme environmental conditions
Technologies
Novel sequencing/detection technologies
Time
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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
Mobile telephony and pervasive computing allow
more rapid networking and greater local data and
processing power
Drivers and trends
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
Standard platforms agreed
Animal DIM mainly by symptoms, not biomarkers
Wild animal surveillance defines zoonotic
hot-spots. Lab informs design of screening test
ICT type systems mature enabling full integration
of POC devices with global networks
Systems
Devices for novel human diseases
POC devices for non-ID applications eg. SMBG and
pregnancy tests
POC devices emerge for professional use
Animal biomarkers for pathogens
Smart objects
Devices for all known pathogens available. Output
fully integrated into international networks
maximising data utility etc
Applications
Detection of pre-symptomatic disease and host
susceptibility
Devices for increasing numbers of known diseases
available. Trend from stand-alone to ICT
integrated devices and from professional to
non-skilled users
Mobile phones measure pulse, blood pressure etc
Immune signatures of human infectious diseases
emerging
Cheaper microfluidic based biosensor technologies
for nucleic acid and protein determination
Immune signatures of animal infectious diseases
emerging
Technologies
POC technologies available for DIM but limited
Trend from PCR to robust simple amplification
technologies and systems capable of functioning
in extreme environmental conditions
Novel sequencing/detection technologies
Now
Near
10
25-30
20
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limited influence prominent influence
Greater importance In 10 25 yrs
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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.