the pipeline for new hiv diagnostics: the promise and the challenges maurine m. murtagh who-unitaid...
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The Pipeline for New HIV Diagnostics: The Promise and the Challenges
Maurine M. MurtaghWHO-UNITAID Co-Hosted Satellite Event
AIDS 2012, XIX International AIDS ConferenceWashington, DC
July 22, 2012
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 comingHumaCount 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.
CD4 Product Pipeline*
2009 2010 2011 2012 2013
HumaCount
Partec Mini
Alere Pima CD4
Daktari
Omega Diagnostics
mBio
Zyomyx
Instruments Disposable
*Estimated - timeline and sequence may change
BD
2014
Monitoring HIV Patients – Device- based POC CD4
Company PointCare/Human Partec Alere Daktari
Platform Name HumaCount CD4 NOW
Partec CyFlow® mini POC
Alere Pima CD4 Test Daktari™ CD4 Counter
Type Desk top; ~26 lbs Bench top portable; ~11 lbs
Bench top portable; ~5.5 lbs
Bench top portable; ~5.5 lbs
Output Absolute & %CD4, WBC, Hb, total lymphocytes
Absolute & %CD4, WBC, total lymphocytes
Absolute CD4 Absolute CD4
Specimen Type 40 µL venous blood 20 µL venous blood 16 µL fingerstick blood 16 µL fingerstick blood
Cost/test ~$10.00 per test, including controls
~$3.96 per test; high volume discounts
$6.00 - $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
Monitoring HIV Patients – Device-based and Disposable POC CD4
Company MBio BD Zyomyx Omega Diagnostics/Burnet
Platform Name Mbio CD4 System BD Point of Care CD4 System
Zyomyx CD4 Counter Omega Diagnostics CD4 Counter
Type Bench top portable; ~6.6 lbs
Bench top; ~11 lbs Disposable cartridge with mechanical mixer/spinner (less than 11 lbs)
Disposable cartridge with reader (~14 ounces)
Output Absolute CD4 Absolute CD4, %CD4 & Hb
Absolute CD4 Absolute CD4
Specimen Type 10 µL fingerstick blood
16 µL fingerstick blood
100 µL fingerstick blood 40 µL fingerstick blood
Cost/test TBD TBD <$8.00 per test $2.00 per test estimated
Number of samples/run
~100 samples per day; TAT 20 minutes (17 minutes in cartridge; 3 minutes instrument reading)
Maximum of ~25 - 30 samples per day; TAT 2- 5 minutes plus 20 minutes of incubation
~40 samples per day; TAT 10 minutes; batch processing TBD
~120 samples per day; TAT ~40 minutes, including incubation
Equipment Cost ($US)
TBD 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
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.
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.
Technology Pipeline – Viral Load and EID*
2012 2013 2014 2015 2016
Alere Q
NWGHF VL
Lynx EIDSAMBA EID SAMBA VL
Liat
WAVE 80 EOSCAPE
Gene XPert
Micronics
Biohelix
ALL
Cavidi AMP
Lumora
Monitoring HIV Patients on ART – Device-based Viral Load/EIDCompany IQuum Alere WAVE80 DRW NWGHF
Platform Name
Liat™ Analyzer Alere Q WAVE80 EOSCAPE-HIV™ System
SAMBA Analyzer Lynx
Type Bench top portable; ~8.3 lbs
Bench top portable; <11 lbs
Bench top portable analyzer with separate processing units
TBD Bench top portable processor unit with cartridge
Output Quantitative or qualitative VL
Quantitative HIV-1 RNA
HIV-1 RNA Semi-quantitative VL or Qualitative for EID
P24 antigen assay for EID
Specimen Type
200 µL plasma or 10 - 50 µL fingerstick blood
25 µL fingerstick or 25 µL heel stick
100 µL fingerstick blood 200 µL plasma (VL) or 100 µL whole blood (EID)
~80 µL blood from infant’s heel
Cost/test TBD TBD <$20 per test TBD ~$7.00 to $15.00 per test
Number of samples/run
~8 - 15 samples per day depending on LOD; TAT 30 - 55 minutes, no batching
Max of ~10 samples per day; TAT 30 – 60 minutes
~50 samples per day with 6-8 processing units and a single analyzer; TAT 50 minutes; random access
4 samples per run; TAT ~90 to 120 minutes depending on assay
~16 samples per day; TAT 30 minutes (plus 10 minutes for blood draw and sample prep)
Equipment Cost ($US)
~$25,000, may be lower in LRS
TBD ~$10,000 for one analyzer with 2 processing units
TBD ~$400 - $700
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.
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
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.
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
Thank you
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