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Fluidigm Obtains CE Mark for Saliva-Based SARS-CoV-2 Assay

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.

"Since introduction of our saliva-based COVID-19 testing solution in the United States, we have seen tremendous interest in our testing technology, and we are gratified by the opportunity to offer one of the first saliva-based COVID-19 tests to be widely available in Europe, where the total addressable market for COVID-19 testing, based on third-party and company estimates, is $5 billion to $7 billion in 2021," Fluidigm President and CEO Chris Linthwaite said in a statement.

Fluidigm received Emergency Use Authorization from the US Food and Drug Administration for the Advanta test in August. The assay was developed in collaboration with researchers at the McDonnell Genome Institute and the Department of Genetics at the Washington University School of Medicine in St. Louis, and is designed to run on Fluidigm's Biomark HD microfluidics platform.

Fluidigm said that it continually conducts in silico analyses to determine the effectiveness of the Advanta test, and has thus far found that none of the published viral mutations meaningfully impact the regions of the viral genome targeted by the assay's primers and probes.