Fluidigm Corporation, South San Francisco, Calif, has received emergency use authorization (EUA) from the 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, designed to be run on the Fluidigm Biomark HD microfluidics platform. Because it is 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 Advanta Dx saliva-based RT-PCR test on the Biomark HD platform provides 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. “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,” says 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 healthcare 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.” For more information, visit Fluidigm.
March 22, 2022
September 9, 2022