Beckman Coulter collaboration to automate high throughput SARS-CoV-2 PCR testing
genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that it has entered into a collaboration with Beckman Coulter Life Sciences (“Beckman Coulter”) to fully automate the entire laboratory PCR testing process for COVID-19. The two companies are working to combine and validate the Genedrive® 96 SARS-CoV-2 Kit on the Biomek i7 automated workstation with saliva samples extracted using Beckman Coulter’s RNAdvance viral extraction chemistry.
The freeze dried bead chemistry of the Genedrive® 96 SARS-CoV-2 test is ideally suited for use on high throughput robotic platforms like the Biomek i7. Stable at room temperature for 4 hours after unsealing, many Genedrive® 96 SARS-CoV-2 Kit 96-well plates can be left arrayed and open in the laboratory environment during the set-up process. The ready-to-go nature of the test bead also removes the fluid dispensing steps required in other assays, increasing the overall throughput of the Biomex i7 compared to using a liquid based test set-up. Accordingly, once validated, Beckman Coulter estimates that this new turnkey solution could process circa 1,000 PCR samples per Biomek installed during a standard 8-hour working day, using just a 0.5 full-time-equivalent in technician time for processing.
Genedrive has already completed initial evaluation of Beckman Coulter’s RNA extraction chemistry to confirm compatibility with the Genedrive 96 SARS-CoV-2 test. Further work is ongoing to validate clinical saliva samples which are a very relevant sample type for applications such as high volume occupational screening. Beckman’s RNAdvance Viral XP has already been listed as an extraction method for swab samples for use with the Centers for Disease Control’s EUA-authorized COVID-19 test in FDA’s FAQ on testing for SARS-CoV-2.
Greg Milosevich, President at Beckman Coulter Life Sciences, said “The integration of Beckman Coulter Life Sciences’ and genedrive’s technologies produces a formidable workhorse solution for specialized laboratories looking to establish new or next level laboratory automation with labor cost reduction. Our ability to fully integrate the RNA extraction process on the Biomek while simultaneously preparing the plates for analysis is a critical step forward in advancing COVID testing workflows. Speed up the testing workflow, reduce labor time and costs. This is the goal of our collaboration with Genedrive and we are excited to be bringing this solution forward to the market.”
David Budd, Chief Executive Officer of genedrive plc, said “We are very pleased to have the opportunity to work with Beckman Coulter in delivering an innovative high throughput COVID-19 PCR solution. It’s been our focus to work with a top tier, high throughput lab automation partner like Beckman to drive uptake of our test and further differentiate our unique capabilities in the market. The combination of our ready to use chemistry with robotics and on-board RNA extraction would give laboratories a unique and rapid workflow that can achieve impressive throughput and result turnaround times. We are both working to have the ongoing validation completed in approximately 6 weeks, with initial introduction in the USA at an already identified clinical laboratory.”
The integrated Genedrive/Beckman Coulter solution will be introduced in selected, relevant geographies subject to validation and any required regulatory approvals.