Improving Access To Diagnostics in the Developing World

Rosanna PeelingProfessor and Chair, Diagnostics Research

London School of Hygiene & Tropical Medicine

Improving Access To Diagnostics in the Developing World

• Global landscape of diagnostics

• Improving access to diagnostic innovation • Fast-tracking the translation of evidence to policy

• Lack of investment in diagnostics R&D - Little industry interest in diagnostics R&D on diseases prevalent in

the developing world, due to a perceived lack of return for investment

• Lack of Access to diagnostic services - lack of investment in diagnostic laboratories - laboratories suffer from frequent stock-outs and critical shortage of staff

• Lack of regulatory transparency - Regulatory approval processes are lengthy and not quality based:

Tests are sold and used without evidence of effectiveness

• Lack of quality standards for test evaluations- Claimed accuracy on product inserts often misleading- Control programmes often misled into buying low quality products

Diagnostics Landscape in the Developing World

In the US, while diagnostics comprise- less than 5% of hospital costs- about 1.6% of all Medicare costs,

their findings influence as much as 60-70% of health care decision-making

Diagnostics are Under-valued

The Value of Diagnostics, Lewin Report, 2005

The 2004 Health Development Report cited the lack of access and unaffordability as two major reasons why services fail

Distance to Nearest Medical Facility for the Poorest 5th of the population:

Country Distance (km)

Benin 7.5Bolivia 11.8Chad 22.9Haiti 8.0Madagascar 15.5Niger 26.9Tanzania 4.7Uganda 4.7Zimbabwe 8.6

Selected from the 2004 World Health Report, p.22

Inequity of Access to Diagnostics

• Patients often self-medicated or purchase drugs from vendors

• May purchase or be given wrong drugs

• Drugs are often sub-standard

• Clinics may not have drugs or diagnostics

Lack of Regulatory Oversight for Diagnostics

In Vitro Diagnostic Devices Regulated

No52%

Yes48%

Yes No

In Vitro Diagnostic Devices Regulation By Region

No 11 9 5 2 2 15

Yes 4 9 4 14 3 7

AFRO AMRO EMRO EURO SEARO WPRO

TDR survey 2002

Test Claimed Accuracy (%)

Sens Spec

Test 1 100 100Test 2 NS NSTest 3 80 >99Test 4 NS NSTest 5 70 100Test 6 93 100Test 7 100 100

WHO Evaluation (%)

Sens Spec

23 99 18 98 63 69 9 100 65 98 22 99 6 99

Blacksell et al. Clin Infect Dis 2006;42:1127

How Good are Dengue Rapid Tests?

NS = not stated

Diagnostic Targets Product

Prototype

Lab & field evaluations

Test adoption

Policy&

Guidelines

Proof of Principle

Technology platform

Product Development and Adoption Pathway for Diagnostics

Regulatory Approval

Shared Rewards

ProductSpecifications

Shared Resources

Shared Risks

Lab on a Chip Platform:

In 1,730 patients with suspected drug-sensitive or multi drug-resistant pulmonary TB at centers in Peru, Azerbaijan, South Africa, and India, Xpert detected 98% of smear +, 90% of smear – ; 98% of RIF resist. and 98% of RIF sens. TB.

Boehme et al NJEM Sept 6 2010

Integrated specimen processing, amplification,and detection of MTB and Rif resistance in sputumIn < 2 hrs

How many TB patients will die while we wait for this new technology to be affordable and available?

• 1.7 billion infected worldwide

• 9.27 million new cases in 2007

• 1.9 million deaths a year

• Up to 50 million are infected with drug-resistant forms of M. tuberculosis (MDR-TB)

Technology Transfer and Local Production

Promises: increase access and affordable pricing

Challenges: • Local production capacity

• TTLP is more attractive to companies if the recipient country has a large domestic market

• How will smaller countries that contributed to the research benefit from novel technologies?

Fast-tracking the translation of evidence to policy

Study settings for Rapid Syphilis Test Introduction

Study Settings Brazil China Haiti Peru Tanzania Uganda/ Zambia

Income ranking Upper middle

Middle Low Lower middle

Low Low

Prenatal: - no PMTCT - with PMTCT

x

x

x

x x

x

High Risk populations

x

x (some)

Remote communities

x x

Health system-wide introduction

x x