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

NEW YORK – Advanced Biological Laboratories announced Thursday its UltraGene Combo2Screen SARS-CoV-2 test received CE-IVD marking. 

The real-time RT-PCR test targets the N gene and E gene regions of the SARS-CoV-2 genome and requires a nasopharyngeal swab specimen. The assay is compatible with "most automatic or manual RNA extraction methods," along with qPCR instruments with at least three channels, the Luxembourg-based company said. Its turnaround time is less than two hours.

The company's US subsidiary AdvancedDx Biological Laboratories said earlier this month it had submitted the UltraGene test for Emergency Use Authorization from the US Food and Drug Administration.

On Tuesday, ABL announced it received CE-IVD marking for its its DeepChek sequencing-based assays for HIV genotyping and drug resistance testing.