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Improving Access  To Diagnostics in the Developing World  Rosanna Peeling Professor 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
Diagnostics Landscape in the Developing  World  Lack of investment in diagnostics R&D  ,[object Object],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 are Under-valued 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 The Value of Diagnostics, Lewin Report, 2005
Inequity of Access to Diagnostics 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		7.5	 Bolivia		11.8	 Chad		22.9	 Haiti		8.0	 Madagascar	15.5	 Niger 		26.9	 Tanzania		4.7	 Uganda		4.7	 Zimbabwe		8.6 Selected from the 2004 World Health Report, p.22 ,[object Object],purchase drugs from vendors ,[object Object],drugs  ,[object Object]
 Clinics may not have drugs or diagnostics ,[object Object]
How Good are Dengue Rapid Tests? WHO Evaluation (%) SensSpec       23		  99       18		  98       63	            69         9	              100       65	                98       22		  99         6                   99 Test	         Claimed Accuracy (%) Sens	    Spec Test 1		100	    100 Test 2		NS	     NS Test 3		80	    >99 Test 4		 NS	     NS Test 5	               70	    100 Test 6		 93	    100 Test 7		100	    100 NS = not stated Blacksell et al. Clin Infect Dis 2006;42:1127
Product Development and Adoption Pathway for Diagnostics  Regulatory Approval Diagnostic Targets Proof of  Principle Product  Prototype Lab & field  evaluations Test adoption  Policy & Guidelines Product Specifications Technology platform Shared Resources Shared Risks Shared Rewards
Lab on a Chip Platform:  Integrated specimen  processing, amplification, and detection of MTB and  Rif resistance in sputum In < 2 hrs 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
How many TB patients will die while we wait for this new technology to be affordable and available? ,[object Object]
9.27 million new cases in 2007
1.9 million deaths a year

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Launch of Policy Cures: Improving Access to Diagnostics in the Developing World - Professor Rosanna Peeling

  • 1. Improving Access To Diagnostics in the Developing World Rosanna Peeling Professor and Chair, Diagnostics Research London School of Hygiene & Tropical Medicine
  • 2. 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
  • 3.
  • 4. Diagnostics are Under-valued 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 The Value of Diagnostics, Lewin Report, 2005
  • 5.
  • 6.
  • 7. How Good are Dengue Rapid Tests? WHO Evaluation (%) SensSpec 23 99 18 98 63 69 9 100 65 98 22 99 6 99 Test Claimed Accuracy (%) Sens Spec Test 1 100 100 Test 2 NS NS Test 3 80 >99 Test 4 NS NS Test 5 70 100 Test 6 93 100 Test 7 100 100 NS = not stated Blacksell et al. Clin Infect Dis 2006;42:1127
  • 8. Product Development and Adoption Pathway for Diagnostics Regulatory Approval Diagnostic Targets Proof of Principle Product Prototype Lab & field evaluations Test adoption Policy & Guidelines Product Specifications Technology platform Shared Resources Shared Risks Shared Rewards
  • 9. Lab on a Chip Platform: Integrated specimen processing, amplification, and detection of MTB and Rif resistance in sputum In < 2 hrs 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
  • 10.
  • 11. 9.27 million new cases in 2007
  • 13.
  • 14. Fast-tracking the translation of evidence to policy