Diagnostics

1
Diagnostics the best kept Secret in Healthcare

• Grasping the benefits of Diagnostics - how
  Government can make it happen

Andy Bufton Chairman, Public and Professional
Relations Steering Group, BIVDA Director,
External and Regulatory Affairs, Abbott
Diagnostics Portcullis House 13 November 2001
2
IVDs in Context

• 5 of Medical Sales
• Less than 1 of Healthcare expenditure
• 60 to 70 of the data on EPR

3
In Vitro Diagnostics What?

• IVDs are used on the well, the sick and the
  treated
• To monitor therapy
• To estimate risk of, or predict, changes in
  health status
• To aid in diagnosis of the symptomatic patient
• To uncover asymptomatic conditions
• To determine the safety of blood products for
  transfusion
• To determine the most efficacious therapy
  (theranostics)

4
In Vitro Diagnostics Where?

• In the Pathology Laboratory
• Fewer, larger laboratories with high throughput
  platforms
• By the patient
• Self-monitoring of Diabetes therapy, Warfarin
  therapy
• Self testing for Pregnancy, health-risk factors
• Point-of-care
• Bedside, operating theatre, and hospital clinics
• In the Community
• Primary Care sites
• In the High Street

5
In Vitro Diagnostics Why?

• 60-70 of the data on the EPR
• To monitor therapy
• Improves outcomes, reduces sequelae of condition,
  lowers costs
• To estimate risk of, or predict, changes in
  health status
• Targets preventative measures, improves health
  levels
• To aid in diagnosis of the symptomatic patient
• Enables correct and timely treatment, improved
  outcomes
• To uncover asymptomatic conditions
• Enables treatment, reduces sequelae, lowers costs
• To determine the safety of blood products for
  transfusion
• Minimises risk of transfusion reactions and
  infections
• To determine therapy (pharmacogenomics and
  theranostics)
• Tailors treatment to the genetic profile of the
  patient, improved outcomes

6
In Vitro Diagnostics Trends

• Site of use
• Pathology Laboratories
• Reducing in numbers, increasing in size, overall
  workload increasing a few p.a.
• Self-use
• Self monitoring for Diabetes control increasing
  15 p.a.
• Small increases in other self-tests, many
  available on the internet
• Point-of-care
• Robust, new technologies allied with IT beginning
  to realise the long heralded Point-of-Care
  revolution in both the Hospital environment and
  in the Community

7
In Vitro Diagnostics Trends

• Role of Diagnostics
• Differential Diagnosis of symptomatic patients
• New, more specific tests, e.g.. Troponin, improve
  outcomes and reduce waste of resources in the
  acute arena
• Monitoring of Therapy
• Optimising therapy such as glycaemic control in
  diabetes by frequent testing
• Prediction and Prevention
• Testing programmes are emerging from around the
  world, delivering improved health outcomes and
  cost benefits
• Uncovering asymptomatic conditions
• Conditions such as Chlamydia infection have a
  long term impact on the health of the individual
  and use of healthcare resources

8
In Vitro Diagnostics Trends

• New technologies and applications
• Improved IT allows Point-of-care diagnostics to
  overcome previous difficulties of Quality
  Assurance and Continuity of Record
• New, proprietary technologies are emerging, e.g..
  relating to automation of cytology screening, HPV
  testing, DNA sequencing for cancer
  susceptibility, genetic analysis technology using
  FISH, risk factors for CHD, and POC technology
  for platelet inhibition therapy, cardiac
  diagnostics and critical care
• Pharmacogenomics offer the opportunity to utilise
  drugs which have efficacy or toxicity according
  to the genetic profile of the patient, possibly
  releasing previously discarded compounds for use
• Theranostics are developing which link
  diagnostics with drug therapy, e.g.
  HercepTest/Herceptin
• DNA probe technologies provide for highly
  sensitive and specific testing for infective
  agents, enabling practical testing programmes of
  an asymptomatic population, e.g.. Chlamydia, HPV

9
In Vitro Diagnostics utilisation in the UK

• The difficulty in transferring funds across
  budget boundaries limits expansion of the use of
  diagnostics in the Pathology Laboratory setting
  (costed as overhead) resulting in the UK having a
  slow uptake of new tests and low usage compared
  to Europe and USA
• The use of diagnostics facilitates many emerging
  issues in healthcare
• Increased quality management and the impact of
  Clinical Governance
• Convenience to the patient and the clinician
  through Point-of Care testing in Primary Care and
  the Community
• Recognition of the cost and health benefits of
  correct and timely treatment, and reduction of
  the sequelae of undiagnosed conditions
• Inter-relationships of Diagnostics and
  Pharmaceuticals, through the study of
  Pharmacogenomics, providing treatment tailored to
  the individual
• Improved public awareness of IVDs through the
  media and the internet

10
In Vitro Diagnostics and the NHS Plan

• We can radically transform the NHS from a 20th
  Century model of Care to a 21st Century Health
  service Alan Milburn,The Parliamentary Monitor,
  July 2000
• The NHS Plan
• NHS Core principle 9
• The NHS will help keep people healthy and work to
  reduce health inequalities
• NHS Core principle 10
• ...developments in science such as the new
  genetics offer important possibilities for
  disease prevention and treatment......
• National Institute for Clinical Excellence
• Modernisation Agency, created to redesign local
  services....
• Patients..... will be able to have tests.... in
  Primary Care centres
• ....effective screening programmes.....
• Improving health outcomes for everyone

11
What should Government be doing?

• Recognising the barrier to UK healthcare
  aspirations, of having the lowest per capita use
  of Diagnostics in the western world
• Acting to manage the use of diagnostics as a
  Strategic Health Resource, rather than buried as
  an overhead in Hospital Trusts
• Asking the right questions of Health Economists

12

• References
• Self-monitoring of Blood Glucose Levels and
  Glycaemic Control, Karter et al, Amer.J.Med 2001
  111 p1-9
• King's Fund Policy Institute's report Counting
  the Cost The Real Impact of Non Insulin
  Dependant Diabetes,1998
• Point-of-Care testing in the Community Pharmacy,
  Moffat.T.,The Pharmaceutical Journal(Vol 267)2001
  267.268
• Prostate Cancer Mortality after introduction of
  PSA mass screening in the Federal State of Tyrol,
  Austria, Bartsch et al, Urology 58 417-424 2001
• Theranostics - the influence of Diagnostics on
  Pharmaceutical Therapy Anna Bromley, PJB
  Publications Ltd., 2000
• Prevention of pelvic inflammatory diseases by
  screening for cervical chlamydial infection.
  Scholes D et al, N Engl J Med 19963341362-6.
• Screening for chlamydial infections and the risk
  of ectopic pregnancy in a county in Sweden
  ecological analysis. Egger M et al, BMJ 1998 Jun
  13316(7147)1776-80
• Acute coronary syndromes. the diagnostic role of
  troponins Hamm CW, Thromb Res 2001 Sep 30103
  Suppl 1S63-9
• Long-term experience with an accelerated protocol
  for diagnosis of chest pain. Caragher TE et al,
  Arch Pathol Lab Med 2000 Oct124(10)1434-9
  
  

Prepared for BIVDA and the Patients Association
by Andy Bufton and Cecilia Brown November
2001 For further information email
coffeedragon_at_compuserve.com