HIV Global Access Program and
New Point of Care Diagnostics
Robert Luo, MD, MPH
Director Medical and Scientific Affairs,
Roche Molecular
Diagnostics
9 September 2015
page 1
© 2015 Roche
HIV Global Access Program
HIV Global Access Program
Viral load testing and early infant diagnosis
US$9.40 cost per test
Virally
On
Diagnose
suppresse
d
treatmen
d
t
Dried Blood Spots to Expand
Access
• Early infant diagnosis
• HIV viral load testing:
Free Virus Elution (FVE)
– Simple method for
dried blood spots
– 90% sensitivity, 100%
specificity at 1000
copies/mL
Strengthening the portfolio
family
The cobas® Liat System addresses a
High
low throughput testing need
cobas® 8800
System
Mid
cobas® 6800 System
cobas® 4800 System
Low
cobas® Liat System
9 September 2015
page 5
© 2015 Roche
cobas® Liat
System
cobas® Liat System
The System
The cobas® Liat System, comprised of the cobas® Liat
analyzer and the cobas® Liat assay tube, is a compact,
innovative real-time PCR platform designed for ondemand STAT testing, enabling confidence in rapid patient
management, at the point of care or in the laboratory.
cobas® Liat Analyzer
cobas® Liat assay tube
A pencil-sized
flexible single-use
tube acts as the
sample vessel and
contains all assay
reagents pre-packed
in tube segments
9 September 2015
page 6
© 2014 Roche
cobas® Liat System
Working Principle of Flow Cycling
Multiple sample processing
actuators compress the
assay tube to selectively
release reagents from tube
segments, allowing the
Heating
& mixture
cooling to
elements
reaction
move
control
from onetemperature
segment to and
motion
sensors monitor the
another
sample processors to ensure
pre-set
assaysystem
conditions
The
optical
then are
met
reads
individual detection
channels for multiplex
assay read out
9 September 2015
page 7
© 2014 Roche
cobas® Liat System
Secure & Simple Workflow
SAMPLE
Add patient
sample to
the cobas®
Liat assay
tube with
provided
transfer
pipette
cobas® Liat
System
Intuitive
touchscreen
user interface
Step-by-step
guided
instructions
SCAN
START
No operator
intervention or
Scan assay
Insert assay
interpretation
tube using
tube into the
built-in
cobas® Liat
No laptops or
barcode
analyzer
additional
scanner
equipment
required
9 September 2015
page 8
© 2014 Roche
cobas® Influenza A/B and cobas®
Strep A assays*
cobas Liat System
High Performance
®
cobas® Influenza A/B
cobas® Strep A
Nasopharyngeal swabs
Throat Swab
Method
RT-PCR
PCR
Time-toresult
~20 minutes
~15 minutes
Approval
CE IVD, FDA
CE IVD, FDA
Sensitivity
A: 100%
B: 100%
98.5%
Specificity
A: 96.8%
B: 94.1*%
94,2%
Sample
Type
Source; cobas® Influenza A/B and Strep product package
inserts
9 September 2015
page 9
© 2015 Roche
*cobas® Influenza A/B and cobas® Strep A nucleic acid tests for use on the cobas® Liat
System
cobas® Liat HIV plans
Two best-in-class point of care
assays
1) Viral load
monitoring
2) Early infant
diagnosis
9 September 2015
page 10
© 2014 Roche
cobas® Liat HIV plans
Design goals
We are committed to developing true point-ofcare HIV assays with the following goals:
No cold chain required, enabling transport at a
Use of whole blood in cartridge
Collaborations with key partners regarding tar
external evaluations, and regulatory approval
9 September 2015
page 11
© 2014 Roche
cobas® Liat HIV plans
Global scale-up plans
In parallel to assay development, we are also
undertaking the following activities:
Scale up of manufacturing to ensure analyzer/a
Expansion of Roche commitment to service
and support globally to include cobas® Liat
analyzer and assays
Availability timeline to be determined
9 September 2015
page 12
© 2014 Roche
Doing now what
patients need next
9 September 2015
page 13
© 2014 Roche