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

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Presentation on theme: "The Pipeline for New HIV Diagnostics: The Promise and the Challenges Maurine M. Murtagh WHO-UNITAID Co-Hosted Satellite Event AIDS 2012, XIX International."— Presentation transcript:

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 several other promising platforms on the horizon. These include the Daktari, mBio and BD platforms as well as disposables from Zyomyx and Omega Diagnostics. 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 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.

3 CD4 Product Pipeline* HumaCount Partec Min i Alere Pima CD4 Daktari Omega Diagnostics mBio Zyomyx Instruments Disposable *Estimated - timeline and sequence may change BD 2014

4 Monitoring HIV Patients – Device- based POC CD4 CompanyPointCare/HumanPartecAlereDaktari Platform NameHumaCount CD4 NOW Partec CyFlow® mini POC Alere Pima CD4 TestDaktari CD4 Counter TypeDesk top; ~26 lbsBench top portable; ~11 lbs Bench top portable; ~5.5 lbs OutputAbsolute & %CD4, WBC, Hb, total lymphocytes Absolute & %CD4, WBC, total lymphocytes Absolute CD4 Specimen Type40 µL venous blood20 µL venous blood16 µL fingerstick blood Cost/test~$10.00 per test, including controls ~$3.96 per test; high volume discounts $ $12.00~$8.00 per test; lower with volume discounts Number of samples/run ~40 – 50 samples per day; TAT 8 minutes; no batching Up to 250 tests/day; TAT 40 – 70 seconds per test after 15 minutes incubation Maximum of ~20 samples per day; TAT 18 – 20 minutes per test ~40 – 50 samples per day; TAT 8 minutes; no batching Equipment Cost ($US) ~$25,000~$9,380; point-of-care package at lower effective cost $6,500 to $12,000~$1,000

5 Monitoring HIV Patients – Device-based and Disposable POC CD4 CompanyMBioBDZyomyxOmega Diagnostics/Burnet Platform NameMbio CD4 SystemBD Point of Care CD4 System Zyomyx CD4 CounterOmega Diagnostics CD4 Counter TypeBench top portable; ~6.6 lbs Bench top; ~11 lbsDisposable cartridge with mechanical mixer/spinner (less than 11 lbs) Disposable cartridge with reader (~14 ounces) OutputAbsolute CD4Absolute CD4, %CD4 & Hb Absolute CD4 Specimen Type10 µL fingerstick blood 16 µL fingerstick blood 100 µL fingerstick blood40 µL fingerstick blood Cost/testTBD <$8.00 per test$2.00 per test estimated Number of samples/run ~100 samples per day; TAT 20 minutes (17 minutes in cartridge; 3 minutes instrument reading) Maximum of ~ samples per day; TAT 2- 5 minutes plus 20 minutes of incubation ~40 samples per day; TAT 10 minutes; batch processing TBD ~120 samples per day; TAT ~40 minutes, including incubation Equipment Cost ($US) TBD ~$200 for mixer/spinner; may be included in cost per test with TBD volume of test cartridges ~1,200 for reader, expected to go to $400

6 One of these, the viral load assay for the Liat platform, may still launch in late Additional platforms will follow over the next few years. 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.

7 Technology Pipeline – Viral Load and EID* Alere Q NWGHF VL Lynx EID SAMBA EID SAMBA VL Liat WAVE 80 EOSCAPE Gene XPert Micronics Biohelix ALL Cavidi AMP Lumora

8 Monitoring HIV Patients on ART – Device-based Viral Load/EID CompanyIQuumAlereWAVE80DRWNWGHF Platform Name Liat AnalyzerAlere QWAVE80 EOSCAPE- HIV System SAMBA AnalyzerLynx TypeBench top portable; ~8.3 lbs Bench top portable; <11 lbs Bench top portable analyzer with separate processing units TBDBench top portable processor unit with cartridge OutputQuantitative or qualitative VL Quantitative HIV- 1 RNA HIV-1 RNASemi-quantitative VL or Qualitative for EID P24 antigen assay for EID Specimen Type 200 µL plasma or µL fingerstick blood 25 µL fingerstick or 25 µL heel stick 100 µL fingerstick blood200 µL plasma (VL) or 100 µL whole blood (EID) ~80 µL blood from infants heel Cost/testTBD <$20 per testTBD~$7.00 to $15.00 per test Number of samples/run ~ samples per day depending on LOD; TAT minutes, no batching Max of ~10 samples per day; TAT 30 – 60 minutes ~50 samples per day with 6-8 processing units and a single analyzer; TAT 50 minutes; random access 4 samples per run; TAT ~90 to 120 minutes depending on assay ~16 samples per day; TAT 30 minutes (plus 10 minutes for blood draw and sample prep) Equipment Cost ($US) ~$25,000, may be lower in LRS TBD~$10,000 for one analyzer with 2 processing units TBD~$400 - $700

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 days 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

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