Advanced Biological Laboratories Receives CE-IVD Registration for its SANGER and for its NGS DeepChek®-HIV Genotyping Drug Resistance Assays

Thursday, May 21, 2020

Advanced Biological Laboratories (ABL) announced today the CE-IVD marking of its DeepChek®-HIV assays, is now available for in-vitro diagnostics. Intended to be used on HIV-1 Group M viruses from patients diagnosed with HIV infection, the assays deliver standardized, open, and flexible solution suited to clinical settings performing sequencing through Capillary Electrophoresis and Next Generation Sequencing (NGS) systems.

The DeepChek®-HIV CE IVD Assays are covering respectively the Protease / Reverse Transcriptase and the Integrase regions of the virus and are intended to be used from input RNA extracted from plasma, serum or whole blood samples. Both assays are highly sensitive and have been validated to process clinical samples as low as 1,000 copies/mL with outstanding performances (100% agreement of analytical reproducibility and repeatability, 100% clinical reproducibility, 99% clinical sensitivity) in all three regions.

Open and flexible, the DeepChek®-HIV CE IVD Assays is a unique and versatile system that can be used under a large variety of laboratory throughput configurations.

“Obtaining CE IVD marking for our DeepChek®-HIV assays will allow virology labs to access a unique and innovative technology, for HIV genotyping diagnostics. ABL will keep standardizing its entire portfolio of applications in virology and microbiology following European and International guidelines to improve the management of patients suffering from chronic diseases on a worldwide basis,” said Dr. Chalom Sayada, CEO of ABL.

HIV remains a major public health threat throughout developed and developing countries. “We are extremely pleased to offer a growing portfolio of standardized diagnostics applications for infectious diseases to our clients and partners, around RNA or DNA detection (UltraGene®), and for sequencing-based genotyping (DeepChek®),” explained Dimitri Gonzalez, Head of the Diagnostics division of ABL.

“The DeepChek®-HIV CE IVD Assays are very flexible and perfectly suited to a broad range of settings running either Sanger or NGS workflows. They have for instance been validated together with the DeepChek® Library Preparation assays on several NGS platforms from Illumina including the iSeq100 instrument,” added Dr. Sofiane Mohamed, Head of Laboratory Research and Development.

“The regulatory efforts ABL has engaged, for certifying its molecular diagnostics applications in continuation of the workaround SARS-CoV-2, needed to be taken for the potential benefits of safety and efficacy to the HIV patients,” added Mr. Ronan Boulmé, Governance, Risk and Compliance Manager of the ABL Group.

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