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
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.
CD4 Product Pipeline*
BD
Alere
Pima
CD4
HumaCount
Zyomyx
mBio
Partec Mini
2009
Omega
Diagnostics
Daktari
2010
2011
Instruments
*Estimated - timeline and sequence may change
2012
2013
2014
Disposable
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
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.
Technology Pipeline – Viral Load and EID*
Micronics
Liat
Alere Q
WAVE 80
EOSCAPE
ALL
Cavidi
AMP
Lynx EID
SAMBA EID
SAMBA VL
NWGHF VL
Biohelix
Gene
XPert
Lumora
2012
2013
2014
2015
2016
Monitoring HIV Patients on ART – Device-based Viral
Load/EID
Company
IQuum
Alere
WAVE80
DRW
NWGHF
Platform
Name
Liat™ Analyzer
Alere Q
WAVE80 EOSCAPEHIV™ 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 HIV1 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 resourcelimited 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