Advanced Biological Laboratories Receives CE-IVD Registration for its DeepChek® Whole Genome SARS-CoV-2 Genotyping Assay, the First CE-IVD Marked Kit for SARS-CoV-2 genotyping clinical applications

SARS-CoV-2 Genotyping using Next Generation Sequencing (NGS) Now Suited to Small, Medium and High-throughput Clinical Settings.

Advanced Biological Laboratories (ABL) announced today the CE-IVD registration of its DeepChek® Whole Genome SARS-CoV-2 Genotyping Assay, the first in-vitro diagnostics kit to aid clinical applications and intended for use on previously diagnosed COVID-19 patients.

This innovative and unique assay, suited to small, medium and high throughput laboratories is intended to be used for amplifying >99% of severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) genome, in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens, and nasopharyngeal wash/aspirate or nasal aspirate specimens) from individuals already tested positive to SARS-CoV-2.

The assay, available in a kit format, provides multiplexed amplicons that can easily be prepared into distinct libraries or pooled with other types of samples and applications (Ex.: HIV, 16s RNA, Tuberculosis…) for subsequent Next Generation Sequencing on many platforms and lab configurations.

It can be bundled with a downstream analysis software to perform a comprehensive list of clinically relevant analyses like SARS-CoV-2 variants identification (including UK, Indian, South African, Brazilian variants of concern databases like Pangolin and Nextclade) for cluster management. It is also used for nucleotide and amino-acid mutations calling and coupled with a constantly up-to-date knowledge database correlating genomic variations with clinical interpretations like virus infectivity or vaccine efficacy. All information is centralized into a PDF report. The analysis and listing of genomic variations by the analysis software, either through a Cloud access or local appliances, is for Research Use Only (RUO). Virologists and physicians use the related genotyping data in conjunction with other patients’ information.

The DeepChek® Whole Genome SARS-CoV-2 Genotyping Assay can be part of a laboratory validated environment for an end-to-end solution including automation (liquid handling robot) and integration with the laboratory information system (LIS).

“After completing CE-IVD registration of our HIV Assays in 2020, we are delighted to offer to virologists another genotyping application for SARS-CoV-2 using the DeepChek® technology which brings lots of efficiency and flexibility to microbiology.” said Dimitri Gonzalez, Head of Diagnostics at ABL. “ABL actively keeps offering high-quality assays and software to microbiology labs covering qPCR et sequencing tests for a growing portfolio of applications which all aim to optimize disease management, our Company’s philosophy since 2000” explained Dr. Chalom Sayada, the CEO of the ABL Group.

To learn more about DeepChek® Whole Genome SARS-CoV-2 Genotyping Assay, please visit

https://www.ablsa.com/laboratory-applications/deepchek_whole_genome_sars-cov-2_genotyping/