Fluidigm’s Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay Secures FDA Emergency Use Authorization

Fluidigm Corporation (South San Francisco, CA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS‑CoV‑2 virus.

Being saliva-based, the Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab. The clinical study associated with the EUA submission demonstrated 100% agreement between the saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and the results from paired nasopharyngeal samples tested with authorized assays.

The test is designed to be run on the Fluidigm Biomark HD microfluidics platform, providing throughput advantages that reduce the impact of capacity-constrained supply chains. The company’s microfluidics technology enables processing of more samples per batch than more traditional, microwell plate-based PCR technology. The Biomark HD platform can generate as many as 6,000 test results per day on a single system.

“Accessible and accurate testing programs that include a non-invasive, saliva-based collection option will be essential throughout duration of the COVID-19 pandemic”, said Andrew Lukowiak Ph.D, CEO of Millennium Health, a high-complexity lab certified under the Clinical Laboratory Improvement Amendments (CLIA) in the US, that has been evaluating the Advanta Dx SARS-CoV-2 RT-PCR Assay in advance of authorization. “In addition to the attractive sample input we chose the Fluidigm workflow 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.”

“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,” said Chris Linthwaite, President and CEO of Fluidigm. “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. The ease of use for health care providers and patients alike will enable improved testing access to the global population. Fluidigm is excited to commercialize this easily administered saliva-based COVID-19 test during a critical phase of the pandemic. In the United States, Emergency Use Authorization for our test coincides with the total number of COVID-19 cases exceeding 5.7 million, underscoring the need for scalable and easy-to-administer testing.”

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