Fluidigm Gains CE Mark for Saliva-Based Assay for COVID-19
Fluidigm has received the CE mark for its Advanta Dx SARS-CoV-2 real-time polymerase chain reaction (RT-PCR) assay, a saliva-based test to detect the SARS-CoV-2 virus.
The company cited clinical studies showing 100 percent agreement between saliva results from the Advanta Dx assay and results from nasopharyngeal samples tested with authorized assays.
The Advanta Dx assay is intended for use by clinical laboratory personnel trained in the techniques of real-time PCR and in vitro diagnostic procedures.
Fluidigm said it plans to offer the assay in Europe for as little as $6 (5 euro) per test.