£2.0011 Oct 2021 10:50
Genedrive PLC (LON:GDR) said it is targeting the end of September or early October for obtaining a European CE marking for its Genedrive COV19-ID Kit.
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.