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Diagnostics Working Group 29 October 2004 Mark Perkins. Partnership. Partner academic and national institutions: 20 workplans and activity descriptions. All India Institute of Medical Sciences Brazilian National TB Network Gambia MRC Industry Partners Institute for Tuberculosis Research

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Diagnostics Working Group 29 October 2004 Mark Perkins

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Diagnostics working group 29 october 2004 mark perkins

Diagnostics Working Group

29 October 2004

Mark Perkins


Diagnostics working group 29 october 2004 mark perkins

Partnership

  • Partner academic and national institutions: 20 workplans and activity descriptions

All India Institute of Medical Sciences

Brazilian National TB Network

Gambia MRC

Industry Partners

Institute for Tuberculosis Research

IUATLD

Johns Hopkins Center for TB Research

KIT (Royal Tropical Institute)

KIT (Korean Institute of TB)

London School Hyg & Trop Med

MSF

Mycobacteria Reference Lab, NL

Partners in Health

PATH

PHRI

Prince Leopold Institute of Tropical Medicine

RELACTB

Research Insitute of Tuberculosis (JATA)

Russian Research Center for Molecular Diagnostics

SA MRC

Sequella Foundation

Statens Serum Institut

Stanford Center for TB Research

Swedish Institute for Infectious Disease Control

TBRU

TDR

TRC

US CDC Div TB Elimination

US CDC National Center for Infectious Diseases

US FDA

US NIH-NIAID

ZAMBART

  • Industry partnership: ~ 50 groups

  • Other fora: CDC/NIH, EC, KIT, Wellcome, IUATLD


Diagnostics working group 29 october 2004 mark perkins

Coordinated strategy for tool-directed research

Coordination of field site strengthening

Diagnostic trial registration and standardization

Consensus on phase IV research priorities

What’s missing?

Designated funding needed for these activities


Dots expansion has not improved case detection rates

Total number of countries

DOTS expansion has not improved case detection rates

No of countries

implementing

DOTS

Global case

notification rate

(All forms of TB)

Global CNR

Year

Countries

Clear need to enhance case detection

to attain global TB control targets

Source:WHO Report 2003: Global Tuberculosis Control: surveillance, planning, financing. WHO, 2003.


Diagnostics working group 29 october 2004 mark perkins

Inefficiency of global TB case detection: 2004

1,421,467

2,465,533

4,910,000

Total8,797,000


Recent history of public sector tb diagnostic development

Recent history of public sector TB diagnostic development

  • Years of denial: 1975 to 1996 “Microscopy is all we need”

  • Years of waiting: 1997 to 2003“Facilitating industry will provide the tools”

  • Years of action: 2004 to 2009“Medical need – evidence – partnership”


Diagnostics working group 29 october 2004 mark perkins

Development of new technologies

Harvesting the best of both worlds to produce public sector goods

Public-private partnership

Private sector

  • Market-driven

  • Product focus

  • IP management

  • Goal-directed R&D

  • Complex project management

  • Financing

  • Manufacture & Distribution

  • Rigid targets/milestones

  • Marketing

Public sector

  • Industry model +

  • Need-driven

  • Partnership

  • Needs driven

  • Altruism

  • Partnership

1900

1950

2000


Diagnostics working group 29 october 2004 mark perkins

FIND will drive diagnostics development from concept to delivery in the health system

Upstream

FIND’s focus

Downstream

Demonstration

Discovery

and research

Development

Evaluation

Market access and distribution

Liaise with funders, pharmaceutical

and biotech companies, research

institutions, academia

Liaise with funders, multi-lateral agencies, NGOs,health ministries,

and agencies like GDF and GFATM

Create network of public and private partners to create effective tests and demonstrate their success

Demonstration

Large-scale

projects

measuring

feasibility and

impact on

disease control

programs

Development

Facilitate,

co-fund,

co-develop

Evaluation

Regulatory-

quality

lab & field

trials

Proof of

principle

Product

in box

Efficacy

Data

Effectiveness

Data

Policy

FIRST BOARD MEETING

Geneva, Switzerland


Diagnostics working group 29 october 2004 mark perkins

Virtual development

Manage portfolio of development, evaluation, and demonstration projects

Develop

Evaluate

Demonstrate

Specimen Bank

Strain Bank

Market Analysis

Mathematical modelling

Specimen/strain Bank

Trial site support

Standardized protocols

Regulatory harmonization

Technical support to NTPs

Usage Guidelines

Access assistance

Operational research

Enabling Infrastructure

Provide intellectual and material infrastructure for diagnostics development


Diagnostics working group 29 october 2004 mark perkins

Purpose

Test Indications

Proposed Priority

Case Detection

Drug susceptibility testing

Latent TB Infection

  • Detect pulmonary TB with high bacterial load (SS+)

  • Detect pulmonary TB with low bacterial load (SS -, Cx +)

  • Detect extra-pulmonary and pediatric TB

  • Detect MDR-TB for treatment

  • Detect MDR-TB for surveillance

  • Detect LTBI for surveillance

  • Detect LTBI for treatment

  • # 1

  • # 2

  • # 3

  • # 4

  • # 7

  • # 5

  • # 6

Priority needs for TB diagnostics


Diagnostics working group 29 october 2004 mark perkins

  • easy & robust lab procedures

  • support for multiple health problems

  • universal platforms

  • dedicated POC devices

  • minimal skill requirements

Segmentation - diagnostic question vs. health system level

RESOLUTION

faster than culture !

DETECTION

more sensitive than smear !

FIRST BOARD MEETING

Geneva, Switzerland


Diagnostics working group 29 october 2004 mark perkins

POSITIVE

NEGATIVE

Tests that revolutionize patient care or disease control

long-term

  • POC smear replacement

  • POC culture replacement

  • 2-day high-TP sensitive lab test for case detection +/- DST for urban centers

  • 2-day lab-free culture replacement

  • Specific predictor of progression from LTBI

short-term

Tests that are significant incremental improvements over existing tools

  • Improved microscopy

  • Simplified or speeded culture

  • Simplified or speeded DST

  • POC smear supplement

2003

2004

2005

2006

2007

2008


Diagnostics working group 29 october 2004 mark perkins

Improving sputum microscopy

1- Fluorescence

2- Polycarbonate filters

3- Immunosedimentation

4- Magnetic beads

5- Chitin

6- Phenol

7- UPS

8- NaOCl

9- CB-18

10- Silica

TDR RFA

Immunomagnetic separation of mycobacteria from sputum for improved fluorescent microscopy

Programmatic use of improved microscopy - differential impact on well and poorly functioning laboratories

Improving the sensitivity of microscopy with a modified membrane filter method to diagnose pulmonary TB

Multicentric evaluation of a smear microscopy techniques for the detection of acid-fast bacilli in sputum specimens

Evaluation of sputum concentration methods for diagnosis of new pulmonary tuberculosis cases by microscopy


Diagnostics working group 29 october 2004 mark perkins

Skin test

Sequella

Chemogen, GoSensor, Chembio, Lionex, DOE, KIT, Proteomesystems

Ag detection

Point of care

Scensive, Mensanna,

Rapid Biosensors

Aerosol

Microscopy

Baldingerst, O’Connell, Xytron

Corixa/IDRI, SSI, NYU, VictoriaU, CSU

Ab detection

Cepheid, Takara, GenProbe, Roche, Eiken, Idaho, Innogenetics, Investogen

Molecular

Biotec, Microphage, Sequella

Phage

District lab

Culture

BD, Biotest, Salubris


Diagnostics working group 29 october 2004 mark perkins

Detection speed

LJ28d

BACTEC10d

TK 14d

Colorimetric solid media

Contamination

Mycobacterial growth


Diagnostics working group 29 october 2004 mark perkins

Phage replication assay for detection or DST

POSITIVE

NEGATIVE


Diagnostics working group 29 october 2004 mark perkins

Exploiting technology for the public good

From concept to affordable delivery in the health system

Research

Policy


2004 2008 portfolio

2004-2008 Portfolio


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