25th Sep 2020 09:07
(Alliance News) - Genedrive PLC on Friday said it has used its SARS-CoV-2 kit to complete the initial testing of Beckman Coulter Life Sciences' RNAdvance Viral RNA extraction chemistry on respiratory swabs.
The molecular diagnostics firm stated that the sensitivity in using the Genedrive kit with samples from upper respiratory swabs is equal to the existing Genedrive SARS-CoV-2 kit specification claim, showing that the Beckman product is suitable for use in the Genedrive testing workflow. It added that the Beckman RNAdvance kit has now been added to the Genedrive 96 SARS-CoV2 instruction for use as a validated extraction protocol for swabs.
The collaboration between Genedrive and Beckman Coulter aims to fully automate the entire laboratory polymerase chain reaction testing process for Covid-19.
"We have a collaboration agreement with Beckman Coulter which includes genedrive validating the analytical parameters of the combined companies' offerings, and Beckman Coulter establishing the mechanics and automation of the overall workflow. Once our product performance is established, we plan to introduce the overall solution in stages, beginning with swab-based claims and then transitioning to saliva claims thereafter, said Genedrive Chief Executive David Budd.
"The Food & Drug Administration places specific prospective clinical performance requirements on validation of saliva samples, which 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," he added.
Shares in Genedrive were trading 7.4% lower at 125.96 pence each on Friday morning in London.
By Ife Taiwo; [email protected]
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