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.
