genedrive PLC (LON:GDR) said its coronavirus testing kit has been verified to work with the RNA extraction technology of its collaboration partner.
Initial testing took place using Beckman Coulter Life Sciences’ chemistry on respiratory swabs in conjunction with gendrive’s 96 SARS-CoV-2 equipment.
This indicated the Beckman product was suitable for use in the genedrive testing workflow.
The tie-up with Beckman included genedrive validating the analytical parameters of the combined companies’ offerings.
Having established performance, the plan going forward is then to introduce the overall solution in stages, beginning with swab-based claims before transitioning to saliva.
In a statement, genedrive chief executive David Budd pointed out that the US Food & Drug Administration, which provides the gold standard for regulatory sign-off, “places specific prospective clinical performance requirements on validation of saliva samples”. This, he added, will take additional time.
“Our initial US evaluation site is currently being installed following the completion of our internal validation studies, after which they will validate the end-to-end solution as required. We will obtain regulatory approvals prior to a final solution release,” Budd explained.