


TB Diagnostics Critical Pathway
Stage-gate process

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1
CONCEPT & FEASIBILITY
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Key Stakeholders
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Bill and Melinda Gates Foundation
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Country Programmes and Partners
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FIND

3
LAB AND CLINICAL VALIDATION
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Key Stakeholders
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Bill and Melinda Gates Foundation
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FIND
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Stop TB - TB REACH
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WHO
Ongoing commercial activities – demand generation, market development, market planning
Can happen in parallel or overlap

4
Regulatory approvals

5
WHO evaluation

6
Country transition to scale (Pre-Launch)

4
REGULATORY APPROVALS

5
WHO EVALUATION

6
COUNTRY TRANSITION TO SCALE PRE-LAUNCH

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