Authorization

Fluidigm Granted FDA Emergency Use Authorization for Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR  Assay for COVID-19

Easy-to-Administer Saliva Test for COVID-19 Available for Immediate ShipmentExtraction-Free, Real-Time PCR Workflow with Capacity of up to 6,000 Tests per Day per System

Demonstrated 100 Percent Agreement with Authorized Nasopharyngeal AssaysSOUTH SAN FRANCISCO, Calif., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Fluidigm CorporationA (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Advantaa?? Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARSa??CoVa??2 virus, designed to be run on theA  Fluidigm Biomarka?? 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.a??Accessible and accurate testing programs that include a non-invasive, saliva-based collection option will be essential throughout duration of the COVID-19 pandemica??, said Andrew Lukowiak Ph.D, CEO of San Diego-based Millennium Health, one of several high-complexity labs certified under the Clinical Laboratory Improvement Amendments (CLIA) inA the United States that has been evaluating the Advanta Dx SARS-CoV-2 RT-PCR Assay in advance of authorization.a??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.a??
See also:
Leave a comment
News
  • Latest
  • Read
  • Commented
Calendar Content
«    Январь 2023    »
ПнВтСрЧтПтСбВс
 1
2345678
9101112131415
16171819202122
23242526272829
3031