Fluidigm Gets EUA Nod For Home Sample Collection Kit For Advanta COVID-19 Assay

The FDA has granted Emergency Use (EUA) approval for Fluidigm Corporation's FLDM AZOVA COVID-19 test collection kit for use with the company's Advanta Dx SARS-CoV-2 RT-PCR Assay on its Biomark HD platform.

• The kit is authorized for at-home self-collection by prescription only for individuals suspected of COVID-19 infection.
• Advanta Dx SARS-CoV-2 RT-PCR assay is an extraction-free saliva-based test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens.
• The assay is only for use under the FDA's Emergency Use Authorization.
• Price Action: FLDM shares are up 2.5% at $4.71 in market trading hours on the last check Monday.