The kit has been in development for more than nine months, which is a longer period than the company would have liked, which it ascribed to “significant technical hurdles” but it has used that time to make improvements to the performance specifications.
The kit, which will initially be launched in Europe, detects the presence of SARS-CoV-2 virus, including the Delta variant, in a nasal swab. The product has been designed to provide an ease of use appropriate for people inexperienced in molecular testing. Positive samples are detected as quickly as nine minutes, with a negative result reported after 20 minutes if no signal is detected.
The testing procedure does not require extraction of the virus from the patient's sample. The company has developed a proprietary lysis (decomposition) buffer that is used to resuspend patient swab material while providing biosafety to users. The exact quantification of biosafety is currently being assessed in an independent UK Public Health England laboratory, genedrive said. A fully biosafe process would present additional or new opportunities and use-cases for point-of-care (PoC) COVID-19 testing.
The four-step workflow uses an 'eye-dropper' liquid transfer process familiar from lateral flow testing and makes the system appropriate for use by those without previous molecular experience.
"We are pleased to have achieved significant milestones in the development of our Genedrive COV19-ID Kit and we have a product in which we are extremely proud,” said David Budd, the chief executive officer of Genedrive.
“Once formally validated, we believe we can make commercial in-roads by expanding the opportunities to get a quick and sensitive molecular test for SARS-CoV-2. The product to date demonstrates a suite of features that have significant competitive advantage: simplicity of workflow, an extraction free procedure, biosafety for the user, multi-gene targeting, rapid time to result, high sensitivity, and cost-effectiveness,” he added.
“Whether in highly vaccinated countries or not, COVID-19 is likely to be an illness that we live with in the long term, necessitating rapid and accurate testing for infection in a wide range of environments, including outside of healthcare settings. Our commercial activities are currently focused on engaging the appropriate commercial partners to be in place in the autumn as the levels of infection undoubtedly rise in many geographies," Budd said.