AMD STAKE HOLDERS MEETING | 7-8 May 2013 1 |

Vision and strategies to

Increase Access to Innovative

HIV Diagnostic Technologies

Willy Urassa

AMD STAKE HOLDERS MEETING | 7-8 May 2013 2 |

Outline

Definition

Introduction

Vision

Broad strategies

Progress so far

Recent experience

AMD STAKE HOLDERS MEETING | 7-8 May 2013 3 |

Expansion of HIV case management through ART has

far outpaced access to diagnostic monitoring of HIV

patients in RLS

AMD STAKE HOLDERS MEETING | 7-8 May 2013 4 |

HIV testing menu

Make initial diagnosis of HIV infection (Antibodies/Antigen, DNA

(Early Infant Diagnosis), Vaccine Induced Seroreactivity (VISR)

Assess eligibility for ART initiation (CD4 testing, VL)

Monitor treatment response (VL, CD4, HIV Resistance,

Toxicity)

Opportunistic Infections

Surveillance (HIV incidence assays)

AMD STAKE HOLDERS MEETING | 7-8 May 2013 5 |

The life span of a Diagnostic test

Product development

Product registration

Patient/Client Testing

Appropriate product

selection, financing,

validation studies

Correct placement,

Functional Lab HS, QA,

Post market surveillance

(PMS)

Premarket

assessment followed

by registration

AMD STAKE HOLDERS MEETING | 7-8 May 2013 6 |

What is the missing link

Lack of appropriate tests at each level – Complexity, affordability,

– Conducive testing environment, sample collection and transportation

Weak laboratory health system – Poor Infrastructure (VCT centers)

– Lack of Strategy for Training and Retention of Personnel (negative impact of incentives)

– Lack of Quality Assurance Testing

– Lack of Referral Laboratory Network [e.g. role of Reference Laboratory testing, (training, supervision, QA)]

Vertical nature of National programs (HIV, Tb, Malaria)

Lack of Regulatory Framework for IVD ( In-country registration, regulation and validation for these technologies, PMS)

AMD STAKE HOLDERS MEETING | 7-8 May 2013 7 |

Vision

To make available accurate, easy to operate, and

affordable HIV tests at all levels of health care for

– Patient management (Serology, CD4, IED, VL, RT and

Monitoring toxicity)

– Prevention

– Surveillance

AMD STAKE HOLDERS MEETING | 7-8 May 2013 8 |

The Current situation of HIV laboratory

testing LEVEL I LEVEL II LEVEL III/IV Assays

HIV Serology Yes Yes Yes RTD, ELISA,

WB

(QA, Algorithms)

CD4 None Yes Yes POC, dedicated,

classical FC, QA

Viral Load NA None Yes Lab based PCR

EID NA None Yes Lab based PCR

Toxicity None Yes Yes Lab based

Bioch, Heam

Opportunistic

Infections

None Yes Yes Simple and lab

based

HIV resistance

NA NA

None? Lab based

Yes: technologies are available but coverage is not adequate

AMD STAKE HOLDERS MEETING | 7-8 May 2013 9 |

The ideal situation of HIV testing

LEVEL I LEVEL II LEVEL III/IV Assays

HIV Serology Yes Yes Yes Rapid assays, ELISA, WB

VISR

CD4 testing NA? Yes Yes POC, dedicated, classical

FC

Viral Load NA - Yes PCR , medium, POC

EID NA - Yes PCR, medium, POC

Toxicity - Yes Yes Lab based Bioch medium,

POC

Opportunistic

Infections

- Yes Yes Simple and lab based

medium, POC

HIV resistance

NA NA

Yes PCR, medium, POC

Yes: technologies are available but coverage is not adequate

AMD STAKE HOLDERS MEETING | 7-8 May 2013 10 |

Broad Strategies - 1

Definition: A plan of action intended to accomplish a specific

goal

Develop appropriate tests for low and high

prevalence areas (POC, Load-and-Go for CD4)

Disease prevalence and infrastructure must be considered during the

development of appropriate diagnostic interventions.

– Define what is required: (Scientist community including WHO)

– Provide Funding to support innovation, release, price negotiation

– Develop thermostable controls and reagents

– Consider: Specimen collection, sample stabilization and robust data

collection

AMD STAKE HOLDERS MEETING | 7-8 May 2013 11 |

Example of Point-of-care testing

Provide same-day results

Decrease loss to follow-up

Allow early identification of

treatment failure

Reduce cost to patients.

May have short half-life

QA/QC oversight is challenging.

Equipment maintenance and service is

difficult,

Increase workload health care workers

Supply-chain logistics of reagents and

supplies

Generally low throughput testing and may not

be cost-effective

Does not eliminate the need to improve/

strengthen lab systems

Where should we place POC tests?

AMD STAKE HOLDERS MEETING | 7-8 May 2013 12 |

Broad Strategies (cont.)

Establish National Quality Assurance programs

– Internal quality Control

– Establish National EQA Scheme

– Establish SOPs

Establish National testing algorithms

Create conducive environment to introduce the tests

– Strengthen IVD Regulatory framework (WHO, IMDRF)

• PMA, in-country registration, PMS

AMD STAKE HOLDERS MEETING | 7-8 May 2013 13 |

Strategies (cont.)

Strengthen laboratory health systems (Training,

Personnel, maintenance,)

Data reporting.

– Establish Laboratory Information System

– Instrument connectivity (Investment in cellular networks to permit

data exchange of results between various levels,.

Integrate Disease programs in General Health Care

Services

AMD STAKE HOLDERS MEETING | 7-8 May 2013 14 |

Progress: Funding

Funding development of POC tests available for few

technologies

Engage with suppliers to accelerate market entry and

negotiate pricing

Conduct operational research to support normative

guidance on the impact, cost-effectiveness, and

appropriate use of POC

Support national planning processes for introduction of

POC

AMD STAKE HOLDERS MEETING | 7-8 May 2013 15 |

Progress: WHO PQ

Seen an incremental number of Product prequalified – Need to widen the scope?

Working with manufacturers of innovative products

Streamlined the PQ process

Strengthening Regulatory capacity of diagnostics in member states (5 pilot countries) – Regulations

– Batch testing

Provide Normative guidance (TWG meeting for POC CD4 Technologies: 6-7 May 2013)

AMD STAKE HOLDERS MEETING | 7-8 May 2013 16 |

Streamlined PQ process for Innovative

technologies

AMD STAKE HOLDERS MEETING | 7-8 May 2013 17 |

Progress: Summary

Product development

Product registration

Patient/Client Testing

Appropriate selection,

financing, validation

studies

Verification

studies,

Registration

Correct placement,

Functional Lab HS, QA,

PMS

Moderate progress

in CD4, but not VL,

resistance testing

IED, Toxicity, VISR Scope of PQ, No NRA, Weak LS, QA, No Post

Market Surveillance,

AMD STAKE HOLDERS MEETING | 7-8 May 2013 18 |

A lot more need to be done!!

Develop and introduce

appropriate diagnostic tests in

all levels

Establish Supportive National systems (Health services

integration, regulatory framework,

maintenance etc.)

Strengthen Laboratory Health

System (QA, personnel, referral

etc.)

AMD STAKE HOLDERS MEETING | 7-8 May 2013 19 |

Changes may be slow: Recent example?

Mission July 2011: Broken un-serviced CD4 instruments, expired reagents, vertical systems, No functional laboratory network, no QA, unmotivated staff: 7 strong recommendations

Mission July 2012: Instrument serviced: still No CD4 testing in the whole country: Training of 22 Lab techs

Mission April 2013: 2/7 recommendations implemented, 2 instrument providing services, Serious plans to: integrate, establish QA, redistribute the instruments according to needs, identify Reference laboratory, thinking about VL, IED, resistance testing, monitoring test, etc.

AMD STAKE HOLDERS MEETING | 7-8 May 2013 20 |

The Day has just started and there is a lot more to be done

before we finally rest!!!

.

Thank you for your attention