2020-11-17 08:58:36 FLDM Fluidigm
11/17/20 11/1708:58 11/17/2008:58 | Fluidigm announces COVID-19 Community Connect programFluidigm Corporation announced COVID-19 Community Connect, a program to link federal, state and local governmental entities, public health agencies, academic institutions, workforces, individuals and a network of high-complexity labs to deliver saliva-based COVID-19 testing. As demand for noninvasive saliva-based COVID-19 testing increases, Fluidigm is serving as a hub to connect interested communities with testing providers. In late August, Fluidigm received Emergency Use Authorization from the U.S. Food and Drug Administration for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARSCoV2 virus. The assay does not require collection via invasive nasopharyngeal swab. The company's clinical study submitted to the FDA demonstrated 100 percent agreement between saliva results from the Advanta assay and results from paired nasopharyngeal samples tested with authorized assays. As an example of the types of connections Fluidigm is creating, Phase2 Labs of Nashville, Tennessee, has adopted the Advanta assay to market COVID-19 testing services to corporate and governmental entities, nursing facilities and on-location film crews. | |
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