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NEW YORK – Fluidigm said on Thursday that it has received the CE-IVD mark for its Advanta Dx SARS-CoV-2 RT-PCR assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus.

The Advanta assay does not require a nasopharyngeal swab, and the company's clinical studies supporting CE mark submission demonstrated 100 percent agreement between saliva-based Advanta results and paired nasopharyngeal samples with other authorized assays, Fluidigm said.

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