Retooling Task Force

Liquid Media for Culture and Drug Susceptibility Testing

• Generic checklist for TB Diagnostics developed by Retooling Task Force adapted specifically for LMC-DST

• Based on expert opinion, further refinement was made

• Checklist was sent to 27 NTP managers with copies to WHO regional representatives soliciting their feedback and comments

• Refined checklist finalized, to be widely disseminated

Similar checklists for each upcoming new technology will be developed as they become available

Checklist of Key Actions for DiagnosticsChecklist of Key Actions for Diagnostics

Dissemination - Global• Stop TB Partnership groups• Relevant WHO Depts, bodies, region/country offices• Global Laboratory Initiative• International organizations eg UNION, IOM• Regulatory authorities• Sponsoring agencies• Technical agencies• Professional associations• National TB Control Programmes and MoHs• NGOs• Patient community and civil society organizations• Test manufacturers• Test developers and evaluators• Untargetted (available on RTF website)

Checklist of Key Actions for LMC-DSTChecklist of Key Actions for LMC-DST

Dissemination - National

• National TB Reference Laboratory• NGOs• Patient community and civil society organizations• Test manufacturers/distributors/agents• Test developers eg FIND country offices• National regulatory authorities• Laboratory equipment suppliers/service• Professional associations • Lab training institutions• Procurement/equipment management services• Authorities at main port of entry for country (delays)• Health systems initiatives at MoH (eg SWAp)• Untargetted (available on national website - NTP?)

Checklist of Key Actions for LMC-DSTChecklist of Key Actions for LMC-DST

Retooling Task Force

What should be in the diagnostics pipeline?

What are the stages in the pipeline?

How are candidate tests positioned along the pipeline?

How is the appropriate health service delivery level or other setting specifications determined

for particular candidate tests?

What evidence is required at each stage to move forward?

Wide stakeholder agreement that there is a need for:

• Inclusive pipeline• More, and more diverse, partners engaged in

development and evaluation of new diagnostics (commercial and non-commercial)

• A clearly-defined common pathway for TB diagnostics development and evaluation

• Clear criteria for defining setting/HS delivery specs• Clear criteria for positioning tests in pipeline• Standards of evidence required for progression

WG Challenges

• Expanding development pipeline• Wide range of technological platforms• Increasing need for collaboration between test

developers• Increasing need to consult with end-users

Reorganization of Workgroup

To promote efficiency in its work and create synergies with partners

Working Group Reorganization

New constituency-based Core Group

8 Sub-Groups around technologies and relevant issues

Revised Strategic Plan

Work-plan for the biennium

Working Group Structure

Core Group

Chair: Giorgio Roscigno (FIND)Secretary: Andy Ramsay (WHO/TDR)

JF de Lavison: Diagnostics Manufacturers AssocArend Kolk: AcademiaVaira Leimane: NTP - High MDR-TB prevalenceSuvita Luka: Patient Community RepresentativeCarol Nyirenda: Patient Community RepresentativeMark Perkins: Product DevelopmentJohn Ridderhof:Laboratory Capacity Strengthening Felix Salaniponi: NTP – High HIV prevalenceFrancis Varaine: Non-Governmental Organization

Core GroupChair: Giorgio Roscigno (FIND)

Secretary: Andy Ramsay (WHO/TDR)JF de Lavison: Diagnostics Manufacturers AssocArend Kolk: AcademiaVaira Leimane: NTP - High MDR-TB prevalenceSuvita Luka: Patient Community RepresentativeCarol Nyirenda: Patient Community RepresentativeMark Perkins: Product DevelopmentJohn Ridderhof:Laboratory Capacity Strengthening Felix Salaniponi: NTP – High HIV prevalenceFrancis Varaine: Non-Governmental Organization

9 SubgroupsOptimizing smear microscopy L.Cuevas/P. Klatser

Culture-based diags and DST D.Moore/J-C Palomino

NAATs L.Rigouts/T Shinnick

Diagnostics for LTBI R.Menzies/K Weldingh

POC tests C.Boehme/R McNerney

Evidence synthesis for TB diags R.O`Brien/M.Pai

TB Diags and Poverty D.Bocca/B.Squire

TB Diags and HIV H.Getahun/B Laughon

TB Diags and children To be confirmed

9 SubgroupsOptimizing smear microscopy L.Cuevas/P. Klatser

Culture-based diags and DST D.Moore/J-C Palomino

NAATs L.Rigouts/T Shinnick

Diagnostics for LTBI R.Menzies/K Weldingh

POC tests C.Boehme/R McNerney

Evidence synthesis for TB diags R.O`Brien/M.Pai

TB Diags and Poverty D.Bocca/B.Squire

TB Diags and HIV H.Getahun/B Laughon

TB Diags and children To be confirmed

Working Group Structure

Priorities in Work-plan• Intensify collaboration within and between

WGs

• To describe an inclusive pipeline

• To develop criteria for describing the intended setting and use of TB diagnostics

Priorities in Work-plan• To develop a Scientific Blueprint for TB diagnostics

development and evaluation that will clearly lay out the stages in the pipeline leading to global implementation and the nature of the evidence required to move through these stages

• To develop criteria to place developing technologies in the "value chain" and determine likely time-lines for availability.

• To work closely with the Retooling Task Force and other partners to facilitate adoption, introduction and implementation of new and improved diagnostics

Retooling Task Force

Diagnostics development and evaluation process

FIND’s focus

Discovery and research

Upstream Downstream

Development

Phase I Evaluation -

Proof of Principle

Phase III Evaluations Field trials

Phase II Laboratory Evaluations

Phase IV Cost-effectiveness

studies

Policy, Prequalification, bulk

procurement, negotiated pricing,

Access

Evaluation

Moving from development and evaluation to retooling

FIND’s focus

Discovery and research

Upstream Downstream

Development

Phase I Evaluation -

Proof of Principle

Phase III Evaluations Field trials

Phase II Laboratory Evaluations

Phase IV Cost-effectiveness

and impact

Policy, Prequalification, bulk

procurement, negotiated pricing,

Access

Evaluation

WH

O E

ndorsement

ND

WG

R

ecomm

endation

ND

WG

Subgroups

NDWG Core Committee

Implem

entation Research

Retooling Task Force

Partnership essentialRoles for partners along continuum

WH

O E

ndorsem

ent

ND

WG

R

ecomm

endation

ND

WG

Subgroups

NDWG Core Committee

DIVERSE PARTNERS

Coordinated global activity

Academia, TDR, STB FIND, Industry, NGOs,

NTPs, Community

WH

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B, T

DR

,

Expert

consultation

WH

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artners

Imp

leme

ntatio

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Retooling Task Force

DIV

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PA

RT

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Country-led

Ac

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ia, T

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, ST

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IND

, In

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