Fluidigm’s Advanta Dx COVID-19 EASE Assay Snags FDA Emergency Use Authorization

South San Francisco, Calif.-based Fluidigm’s Advanta Dx COVID-19 EASE assay has received Emergency Use Authorization from the FDA.

The polymerase chain-reaction (PCR) test is authorized for detection of nucleic acid from the SARS-CoV-2 virus in nasal swab specimens from individuals suspected by a healthcare provider to have COVID-19.

The real-time reverse transcription PCR test is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 and meet the requirements to perform high-complexity tests.