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Advanced Biological Laboratories SARS-CoV-2 Genotyping Test Receives CE Mark

NEW YORK – Advanced Biological Laboratories announced on Tuesday that its DeepChek Assay Whole Genome SARS-CoV-2 Genotyping V1 has received CE-IVD registration.

The test, which leverages RT-PCR technology followed by next-generation sequencing, is intended to be used to amplify the whole genome of SARS-CoV-2 in upper respiratory samples from people who have already tested positive for the virus. It aims to identify the virus by variant to assist in clinical applications, the company said in a statement.

ABL's test covers more than 99 percent of the SARS-CoV-2 whole genome and can be used with a variety of PCR and NGS platforms, including Illumina's iSeq-100 and MiSeq instruments and Thermo Fisher Scientific's ProFlex PCR instrument. The test, which has an estimated turnaround time between 48 and 72 hours, is available in a 48-kit package and is adaptable to low- and high-throughput labs.

ABL noted that the assay is also compatible with downstream analysis software to identify SARS-CoV-2 genomic variations and variants such as the B.1.1.7 and B.1.351 variants, list genomic variations associated with clinical interpretations, and provide a summary report for clinicians.

In April, ABL received the CE-IVD mark for its RT-PCR UltraGene SARS-CoV-2 Triplex Assay and last year the company received CE-IVD marking for its UltraGene Combo2Screen SARS-CoV-2 qPCR assay.