![](/media/fk4b3you/testing-hp.jpg)
![](/media/tqshppvx/injection-hp-p-800.jpg)
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TB Diagnostics Critical Pathway
Stage-gate process
![](/media/vyydu4ys/stage-0.jpg)
0
![](/media/k4om1cui/stage-1.jpg)
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
![](/media/bckfkx22/stage-3.jpg)
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
![](/media/0daoo5pe/stage-4.jpg)
4
Regulatory approvals
![](/media/bvykp1vt/stage-5.jpg)
5
WHO evaluation
![](/media/fsvlzlg4/stage-6.jpg)
6
Country transition to scale (Pre-Launch)
![](/media/0daoo5pe/stage-4.jpg)
4
REGULATORY APPROVALS
![](/media/bvykp1vt/stage-5.jpg)
5
WHO EVALUATION
![](/media/fsvlzlg4/stage-6.jpg)
6
COUNTRY TRANSITION TO SCALE PRE-LAUNCH
![](/media/laopry0z/stage-8.jpg)
8
![](/media/zpyblmyk/stage-9.jpg)
9