Genedrive 96 Exporter is a new in-vitro diagnostic medical device (IVD) software module for automated results interpretation of the Genedrive 96 SARS-CoV-2 Kit.
The software displays the interpreted data as '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 basis or as part of a sample group.
The CE-marked proprietary format 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 new Genedrive 96 Exporter software provides a significant improvement to the native software found on third party PCR [polymerase chain reaction] platforms, allowing for a more seamless workflow for melt curve PCR analysis in COVID-19 PCR testing when using our assay,” David Budd, the chief executive officer (CEO) of genedrive said in a statement.
“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," he added.
In a separate announcement, the molecular diagnostics specialist said revenue for the year to the end of June was in line with expectations at £1.0mln, down from £2.4mln the year before. As previously announced, revenues have been hit hard by the disruption caused by the coronavirus pandemic.
The company ended the financial year with cash of £8.2mln, up from £3.5mln six months earlier, while following the conversion of a US$8.0mln GHIF bond last month, the company has significantly reduced the level of debt on its balance sheet.
The company has more than £1.0mln of indicative orders for its Genedrive 96 SARS-CoV-2 test waiting to be filled once the necessary regulatory approvals have been secured.
In general, regulatory approvals are taking longer than anticipated and the regulatory agencies the company is engaged with are unable to provide definitive timelines for approvals, which genedrive believes is due to a significant increase in their workloads during the current global health crisis.
The company is also working to ensure that CE marking claims for the Genedrive 96 SARS-CoV-2 test can be expanded to include a broader range of laboratory systems, and therefore increase the potential customer base for this test.
The company 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 to this customer.
Despite some initial concerns around the impact of lockdown on the Antibiotic Induced Hearing Loss (AIHL) project, the UK National Health Service evaluation programme has continued to run during the past few months. After a slow period, the programme pace has increased somewhat as lock-down measures have eased and the company remains optimistic of completing the project and achieving the autumn 2020 timeframe for commercial launch with Inspiration Healthcare PLC.
The impact of COVID-19 on the hepatitis C virus (HCV) market is less clear as many developing world healthcare systems continue to focus on the COVID-19 pandemic, genedrive said.
The company achieved World Health Organization pre-qualification status for its HCV product in May 2020 but only expects to see moderate sales traction in the near-term as countries focus on coronavirus.
The development of a CoV-2 point of care test for the Genedrive system remains targeted for the end of the calendar year.
"We remain encouraged by the interest in our Genedrive 96-SARS-CoV-2 test,” said CEO Budd.
“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. 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," he added.