Advanced Biological Laboratories (ABL) Launches HIV and HCV DeepChek® SingleRound Genotyping and Sequencing Assays

LUXEMBOURG–(BUSINESS WIRE)–Today Advanced Biological Laboratories (ABL) announced the launch of the
DeepChek® SingleRound HIV and Hepatitis C Virus (HCV) Genotyping and
Sequencing assays.

These two assays are the first in its virology reagents portfolio. The
DeepChek® SingleRound assays are currently available for Research Use
Only.

The DeepChek® SingleRound HIV RT-PCR and Sequencing Assay detects all
the major HIV-1 subtypes (B, C, F, A1, D, 02_AG …). It combines all the
reagents (including enzymes) and protocols required to perform the
amplification and sequencing of Reverse Transcriptase, Protease and
Integrase. These are HIV coding regions known to harbor mutations
inferring decreased susceptibility and drug resistance to anti-HIV
drugs. A systematic nested amplification step is not needed. The overall
performance in sensitivity and susceptibility is comparable to available
commercial kits. The amplification step was successful in samples with
low viral load, down to 300 copies/mL.

The DeepChek® SingleRound HCV Genotyping and Subtyping Assay detects
genotypes 1, 2, 3, 4, 5 and 6 and more specifically subtypes 1a and 1b
by targeting NS5B and 5’UTR HCV coding regions. It exhibits a Limit of
Detection (LOD) of 1000 IU/mL.

The DeepChek® SingleRound assays are designed for use on Sanger or on
next-generation sequencing (NGS) instruments. For Sanger sequencing it
consists of the DeepChek® SingleRound RT-PCR, a semi-automated
amplification with all Sanger reagents and required enzymes. For NGS, in
addition to the RT-PCR step, the library set-up requires fragmentation
and indexing kits according to the NGS system used are precised.

For efficient data analysis and clinical genotyping report generation,
DeepChek® SingleRound assays are bundled with the ViroScore® and
DeepChek® software, both CE-marked for IVD use, for Sanger and NGS,
respectively. The automated workflow enables computerized reporting and
rapid and accurate genotyping, subtyping and drug resistance
interpretations across the complex HIV and HCV genomes. The overall
workflow is very efficient for both Sanger and NGS platforms.

End-users can choose between easy-to-interpret reports for clinicians
and more advanced bioinformatics and results interpretation for
virologists and researchers. The hosting server solution includes the
ViroScore® and DeepChek® workflow and also eases integration with
laboratory information systems, data exchange and tracking of
patient-sample identifiers for traceability.

“We have turned a new page at ABL by promoting reagents and software.
Both products can be used separately but the value and
cost-effectiveness lies in the bundling and automation”, stated Dr.
Chalom Sayada, CEO of ABL and former Vice-President at Visible Genetics,
which developed the first HIV genotyping kit (TruGene™ HIV-1) approved
by the FDA and CE-IVD marked. “We aim to offer cost effective, highly
reliable and efficient new generation genotyping assays and achieve
substantial market shares within the next two years. ABL especially
intends filling the gap left after the termination by Siemens HealthCare
of the TruGene HIV and HCV kits and take advantage of the emergence of
NGS platforms which require vertical detailed and versatile reporting
solutions; infectious diseases included”, added Dr. Sayada. “Soon we
will have additional reagents for HCV drug resistance targeting NS5A,
NS3 and NS5B regions, bacteriology typing and drug resistance, and focus
on CE-marking for IVD use early in 2016”.

ABL is introducing the DeepChek® Assays together with ViroScore® and
DeepChek® during the AMP annual meeting in Austin, at booth 412.

About Advanced Biological Laboratories (ABL) S.A.
Advanced
Biological Laboratories (ABL), S.A., is a Medical Data Technology
company founded in 2000 as a spin-off from CRP-Santé Luxembourg. ABL
took control of TherapyEdge, Inc. in 2004 and in 2013 acquired the
rights to all viral hepatitis B & C related assets from EVIVAR MEDICAL,
respectively. ABL has a comprehensive suite of healthcare management
products, including TherapyEdge®, ViroScore®, SeqHepB, DeepChek®,
VisibleChek®, HepatiC™ and the DPM which are used for data and patient
management, monitoring and personalized reporting applications. In 2012,
some of ABL’s products also received CE-marking for IVD use. ABL’s
products, ViroScore® Suite and DeepChek®, are for research use only in
the United States, and the upcoming data processing module is an FDA
registered class I medical device. ABL’s products offer infectious
disease clinicians and virology laboratories optimal and efficient IT
solutions, for sequencing, clinical genotyping, and drug resistance
analysis, including powerful fully integrated databases and analysis
systems combining standard and high-throughput Next Generation
Sequencing data.

Contacts

Advanced Biological Laboratories (ABL):
Dr. Chalom Sayada,
Tel: +352 2638 9676 20