The Genedrive Beckman collaboration seeks to fully automate the entire laboratory PCR testing process for COVID-19 PCR. The two companies are continuing to validate the Genedrive® 96 SARS-CoV-2 Kit on the Biomek i7 automated workstation with both saliva and respiratory swab specimens extracted using Beckman Coulter Life Sciences’ RNAdvance viral extraction chemistry. While saliva is potentially a more difficult sample type compared to upper respiratory swabs, work completed to date has been very promising and the Company remains confident that it could be validated with clinically acceptable performance.
David Budd, Chief Executive Officer of genedrive plc, said ”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. The FDA 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.”
