(AIM:GDR ) has developed Genedrive® 96 Exporter, a new in-vitro diagnostic software module for automated results interpretation of its Genedrive® 96 SARS-CoV-2 Kit.
The software, which has been developed to provide workflow and usability advantages, displays the interpreted data as either 'positive' or 'negative' in a graphical user interface and as an exportable report.
The interpreted data is then available for further inspection on an individual sample, sample group, or entire 96 well plate basis by the user.
The CE-marked Genedrive® 96 SARS-CoV-2 Kit is designed to detect active COVID-19 infection. It streamlines laboratory workflow, allowing more tests to be performed in a day.
During CE-IVD evaluations, the Genedrive® 96 SARS-CoV-2 Kit achieved 100% sensitivity and 98% specificity in randomised clinical specimens.
The group also received over £1m of indicative orders for its Genedrive® 96 SARS-CoV-2 kit which is waiting to be filed once the necessary regulatory approvals have been approved.
Currently, regulatory approvals are taking longer than anticipated with no definitive timeline for approvals, which the group believes is due to a significant increase in the agencies’ workload.
Genedrive is also working to ensure that CE marking claims for the Genedrive® 96 SARS-CoV-2 test can be expanded to increase the potential customer base for this test.
The company said it has pathogen detection orders to fulfil for the US Department of Defense (DoD) and is confident of first half sales of both Genedrive® units and assays.
Despite some initial concerns about the group’s Antibiotic Induced Hearing Loss (AIHL) project, the company remains optimistic of completing the project and achieving the autumn 2020 timeframe for commercial launch with Inspiration Healthcare.
“We are working to secure regulatory approvals in the territories we are focused on, which are also key to signing additional partners to expand our commercial footprint,” said Budd.
He added, “The critical role of testing is absolutely clear as the world continues to deal with the pandemic and while the competitive landscape and overall markets continue to evolve, our target markets combined with the unique aspects of the CoV-2 Test give us significant confidence in delivering successful commercial outcomes in the near future."
The development of a CoV-2 point of care test for the Genedrive system remains targeted for the end of the calendar year.
“The new Genedrive® 96 Exporter software provides a significant improvement to the native software found on third party PCR platforms, allowing for a more seamless workflow for melt curve PCR analysis in COVID-19 PCR testing when using our assay,” said CEO, David Budd.
He added, “The tool was developed by repurposing the clinically validated software algorithms we use in our point-of-care Genedrive® instrument software, underscoring the versatility and value in our core technology platform and providing additional differentiation to genedrive's offerings in the COVID-19 testing market."
Shares in Genedrive opened 12% down to 89.5p in early morning trading, but still up remains one of our best performers in the Vox Markets COVID-19 Index year to date.
In a separate announcement, Genedrive said revenue for the year ended 30 June 2020 was in line with expectations at £1.0m, down from £2.4m in 2019.
As previously announced, the group has seen a significant impact as a result of COVID-19 pandemic across its pre-existing business activities.
However, Genedive closed the year with cash balances of £8.2m (31 December 2019: £3.5m) following a successful £7 million equity fundraise in May 2020 which largely reduced its debt.
As a result, it ended the year with a stronger balance sheet and said it is well-funded to execute on new opportunities in COVID-19 testing and its product development pipeline.
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