The Pipeline for New HIV Diagnostics: The Promise and the Challenges

1. The Pipeline for New HIV Diagnostics: The Promise and the Challenges Maurine M. Murtagh WHO-UNITAID Co-Hosted Satellite Event AIDS 2012, XIX International AIDS Conference Washington, DC July 22, 2012

2. There are already several POC CD4 platforms on the market and more are coming HumaCount CD4 NOW (formerly PointCare NOW), the Partec mini-CyFlow and the Alere Pima CD4 Test are already on the market. The Alere Pima CD4 Test has been on the market since November 2009. In 2010, about ~650 devices were placed and ~580k tests sold; in 2011, this increased to ~1650 devices and ~900k – 1m tests sold; in 2012 through June, 750 analyzers have been placed, and 740k tests sold. There are several other promising platforms on the horizon. These include the Daktari, mBio and BD platforms as well as disposables from Zyomyx and Omega Diagnostics.

3. CD4 Product Pipeline* BD Zyomyx Alere Pima CD4 HumaCount mBio Omega Diagnostics Partec Mini Daktari 2014 2009 2010 2011 2013 2012 Instruments Disposable *Estimated - timeline and sequence may change

4. Monitoring HIV Patients – Device- based POC CD4

5. Monitoring HIV Patients – Device-based and Disposable POC CD4

6. New Options for Viral Load Monitoring and EID are also on the Horizon A number of new Viral Load/EID POC diagnostics are in development. These will have lower instrument and per-test costs, but will also have lower throughput than lab-based systems. One of these, the viral load assay for the Liat platform, may still launch in late 2012. Additional platforms will follow over the next few years.

7. Technology Pipeline – Viral Load and EID* Micronics Liat AlereQ WAVE 80 EOSCAPE ALL Cavidi AMP Lynx EID Biohelix SAMBA EID SAMBA VL Gene XPert NWGHF VL Lumora 2013 2016 2015 2014 2012

8. Monitoring HIV Patients on ART – Device-based Viral Load/EID

9. What does it take for POC diagnostic technologies to be “game changers”? • There are some very promising POC diagnostics in the pipeline. In order for them to be “game changers”, they will need to help compensate for diagnostic system weaknesses in resource-limited settings: • Human Resources: Lack of trained staff, high turnover and insufficient training opportunities • Supply Chain: Ensuring the efficient and reliable supply of essential diagnostic products throughout the laboratory system is a significant obstacle to diagnostic delivery. Long and difficult transport of test reagents and consumables are the norm often under extreme temperature conditions, including temperature spikes. • Service/Maintenance: Lack of diagnostic equipment and frequent and prolonged breakdowns of equipment (lasting months and sometimes years) • Diagnostic Errors: Studies have shown that even for simple tests, quality-controlled and reproducible testing remains a major challenge in resource-limited settings; test errors are observed frequently.

10. Priority Characteristics of POC Diagnostics • In addition to strong technical performance and cost effectiveness, in-country research has demonstrated the following high priority characteristics for POC diagnostics: • Durability: device with no electronic or mechanical maintenance beyond simple tasks; rugged device that will tolerate high temperature tolerances and will tolerate shock and vibration; cartridges with long shelf life and ability to survive extreme temperature fluctuations and humidity; no cold chain or clean water required; battery back-up • Ease of use: simple sample preparation (few operator steps); ability to use unprocessed sample specimens; no operator intervention required during analysis; self-contained kits; little operator calibration; simple user interface and read-out • Training: test simple enough that its use can be explained to a healthcare worker in a day’s training or less; test simple enough to permit informal training among healthcare workers • Self-contained Quality Control: if device-based, device designed to cover a large number of quality issues rather than leaving them to staff: e.g., detecting expired kits (reject); detecting inadequate sample volume (reject); running process control

11. The Limitations of POC Testing • POC testing has the promise to fill gaps in access and capacity, and there are some exciting POC diagnostics either here or coming over the next few years. But, there is no silver bullet technology yet. Understanding the realistic value and preparing for the implementation challenges is imperative to increase access to the right populations in the right way.

12. Acknowledgments UNITAID The Bill & Melinda Gates Foundation Dr. Trevor Francis Peter Advanced Liquid Logic, Alere, BD Biosciences, Biohelix, Burnet/Omega Diagnostics, Cavidi, Cepheid, Daktari Diagnostics, Diagnostics for the Real World, Human/PointCare, Iquum, Lumora, Mbio, Micronics, Northwestern Global Health Foundation, Partec, WAVE80 and Zyomyx

13. Thank you