HCV Diagnostics Technology Landscape
AIDS 2014, 10th International AIDS Conference
21 July 2014
Maurine M. Murtagh
UNITAID Consultant
Current HCV Testing Continuum
Need for Service
ILLUSTRATIVE
Screening
Confirmatory
Test
Genotyping
Serodiagnosis
RDT
HCV
RNA
or Ag
Line
Probe
RT
PCR
Fibrosis
Staging
Biopsy
BioMarker
Prognostic
Markers
IL28B
Treatment
Monitoring
HCV
RNA
With available HCV treatment, the testing cascade for HCV is complex and expensive,
which means that it is very challenging for resource-limited settings.
With the potential availability of DAAs, a simplified HCV testing algorithm should be
possible, which will help make HCV diagnosis and monitoring attainable in resourcelimited settings.
Potential HCV Testing Continuum - DAAs
Need for Service
ILLUSTRATIVE
Screening
Confirmatory
Test
Fibrosis
Staging
Serodiagnosis
RDT
HCV
RNA
or Ag
Biomarker
TE
Test of Cure
HCV
RNA
or
Ag
Screening and confirmatory testing will still be needed, although these might be combined
into a single qualitative assay to detect the presence of HCV RNA or Ag.
Fibrosis staging may be needed, although perhaps not for HIV co-infected patients, and
testing HCV clearance/cure at the end of treatment and post-treatment, will also be
required. But, qualitative HCV RNA or Ag technologies used for confirmation/diagnosis of
HCV could also be used for clearance/cure testing.
Pipeline Technologies – Confirmation/Cure
With all-oral HCV regimens expected in ~2016, it is anticipated that baseline
quantification of HCV may not be necessary. It is also anticipated that with
shorter and more effective regimens, quantitative HCV RNA testing for treatment
monitoring can be eliminated.
It would then be possible to use a highly sensitive qualitative HCV RNA assay or
HCV Ag assay to confirm the presence of the virus (for diagnosis) and to use the
same assay again at the end of treatment and at a defined point post-treatment
to confirm cure.
Existing Technologies – Confirmation/Efficacy/Cure
Currently, both qualitative HCV testing for confirmation of HCV diagnosis and
quantitative HCV viral load testing for monitoring treatment efficacy and
clearance and is done on sophisticated platforms requiring highly trained
personnel in central laboratory settings.
Assays include those
from Roche (COBAS®),
Abbott (m2000), Siemens
(VERSANT®), and others.
These pose access
challenges similar to
those for HIV viral load
testing.
Solutions include the use
of DBS for HCV viral load
testing as well as the
introduction of platforms
that can be used nearer to
the point of patient care.
Some Potential HCV RNA and HCV Ag Products
COMPLEXITY
(Low)
(Medium)
Low-Resourced Lab
(minimal to no sample prep)
Assay Type
Point-of-Care
Wave 80
EOSCAPE™
IQuum
Liat™
Analyzer
Cepheid
GeneXpert®
Quantitative
Molbio
Truenat
HCT
Alere q
Daktari HCV
Quantitative
Viral Load
PCR NAT
bDNAbased NAT
PCR NAT
RT PCR
PCR NAT
HCV Core
Antigen,
Portable,
~8lbs
Pangenotypic
Portable,
<11lbs
Portable, 5.5lbs
Yes
Unknown
Yes
Yes
Unknown
Unknown
Time to
Result
70 min
30-35 min
~95 min
~60
30-60 min
30 min
Battery Life
8 hours
Unknown
AC Power
8 hours
8 hours
Up to 3 days
Device Cost
<$10,000
~$25,000
$17,000
$8,000
TBD
$5,000
Cost/ Test
<$20
TBD
$10 - $17
$15
TBD
$8
Market
Launch for
HCV
Not known
Not known
Ex-US launch
early 2015
Not known
Not known
Late 2015
Conclusions/Questions
More and better RDTs for screening HCV are needed, including RDTs that can
reliably detect HCV in HIV co-infected patients.
More studies are needed to demonstrate that HCV Ag assays that detect HCV
core antigen are sufficiently sensitive for use in diagnosis and testing for HCV
clearance/cure.
While there is a reasonable pipeline of HCV viral load assays for use on platforms
at the point of care in resource-limited settings, most developers are aiming for
fully-quantitative assays. Is this what is really required in light of the advent of
all-oral HCV treatment regimens?
Conclusions/Questions
In general, developers need guidance from
stakeholders with respect to the key market
requirements for HCV screening/diagnosis as
well as monitoring, if any, and/or
clearance/cure testing for HCV. Stakeholdervetted TPPs could be helpful in this respect.
If the cost of DAAs can be brought down to
levels where all-oral treatments for HCV are
obtainable in resource-limited settings, the
required diagnostic technologies need to be
ready and appropriate for implementation.
Like HIV, this testing landscape is likely to
include both lab-based platforms and
diagnostics for use at or near the point of
patient care.
Acknowledgements
Thanks to UNITAID for funding my diagnostic landscape work.
Thank you