FDA awards Emergency Use Authorization for Advanta Dx SARS-CoV-2 RT-PCR Assay in COVID-19 detection.- Fluidigm Corp

Fluidigm Corporation announced it 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 percent 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 SARS-CoV-2 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. This test has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for use by authorized laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meet requirements to perform high-complexity tests. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, unless the authorization is terminated or revoked sooner.