RE: FDA priorities6 May 2021 11:52
Maestro the EUA is specifically for the GDR Test! They don't need a separate EUA for every device it can run on!!!!!
Beckman have validated the GDR test beads on the Biomeki7
David Budd, CEO of genedrive plc, said: "genedrive submitted its application to the FDA in May of this year but owing to the volume of applications received we are still waiting for EUA review. However, in order to support the Beckman Biomek system's transition into clinical use and exploit commercial opportunities, the product needs to be commercially available in the United States to end users. We are confident in the performance claims of our assay and have generated independent evaluation data in the United States at non-automated sites and our automated Biomek installations which confirm our product claims."