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Fluidigm Saliva Test for SARS-CoV-2 Gets FDA Emergency Use Authorization

NEW YORK – Fluidigm said on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration 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.

Fluidigm's stock soared on the announcement. In early Wednesday trading on the Nasdaq, shares of the company were up around 29 percent at $11.34.

The test 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 the Fluidigm Biomark HD microfluidics platform.

Fluidigm said that the clinical study associated with the EUA submission demonstrated 100 percent agreement between the saliva-based assay and results from paired nasopharyngeal samples tested with already authorized molecular tests.

Andrew Lukowiak, CEO of San Diego-based Millennium Health, one of several high-complexity CLIA-certified labs in the US that has been evaluating the Advanta assay, noted in a statement that his organization chose to work with Fluidigm's platform and test because of its ability to use saliva as a sample and "because it combines extraordinary throughput per system with a robust supply chain from a trusted large-scale supplier. We believe this approach will enhance testing coverage in critical populations."

Fluidigm said that its test on the Biomark HD platform provides throughput advantages that reduce the impact of constrained supply chains for traditional RT-PCR testing using nasopharyngeal swabs. The company's microfluidics technology enables processing of more samples per batch than microwell plate-based PCR technology and can generate as many as 6,000 test results per day on a single system.

"We have seen extraordinarily strong customer interest in our high-throughput saliva-based test, including many new purchases of Biomark HD systems to enable its adoption," Chris Linthwaite, President and CEO of Fluidigm, said in a statement. "We have a high degree of confidence that this new test will not only enhance testing capacity but will also significantly improve speed to results and scale."

Fluidigm was one of several organizations recently selected by the National Institutes of Health's National Institute of Biomedical Imaging and Bioengineering for a project under the Rapid Acceleration of Diagnostics (RADx) program, which fast-tracks development and commercialization of innovative technologies to significantly increase US testing capacity for SARS-CoV-2.

The project, with a total proposed budget of up to $37 million, is intended to expand capacity and throughput for COVID-19 testing with Fluidigm microfluidics technology through increased microfluidics manufacturing capacity and a novel barcoding chemistry.

Also, in April, a public-private partnership in Oklahoma announced it would begin high-throughput molecular testing for SARS-CoV-2 infections using a lab-developed RT-PCR assay run on Fluidigm's platform.

In addition, Fluidigm said in March that it was collaborating with a consortium of medical schools led by the Icahn School of Medicine at Mount Sinai to develop a Biomark-based epigenetic test for the early detection of SARS-CoV-2 infection.

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