Genedrive makes progress with Covid-19 test development

Molecular diagnostics company Genedrive updated the market on the development of its ‘COV19-ID Kit’, a rapid point-of-care molecular test for SARS-CoV-2 detection designed for its ‘Genedrive instrument’, on Thursday.

The AIM-traded firm said it had been developing a new, “best-in-class” point-of-care molecular workflow and assay for more than nine months, and was now releasing its current performance specifications as it moved towards formal clinical qualification and regulatory filing.

While acknowledging the longer-than-anticipated development time, the board said the company had overcome “significant” technical hurdles, and also further improved performance specifications alongside evolving marketplace requirements.

Key specifications of sensitivity, specificity, speed, ease-of-use and scalability had all been improved or addressed.

The firm said the COV19-ID Kit detects the presence of SARS-CoV-2 virus in a nasal swab, and was designed to provide an ease-of-use appropriate for people inexperienced in molecular testing.

Positive samples are detected as quickly as nine to 10 minutes, with a negative result reported after 20 minutes if no signal is detected.

In contrast to many competitor products, the firm said the test targeted two genes of the SARS-CoV-2 genome, and was shown to be inclusive of all current variants of concern, including the ‘Delta’ variant.

The intent of a two-gene design was to provide additional robustness to new emerging variants in the future.

Genedrive said the specificity of the test during design verification was 100%, with a polymerase chain reaction comparable limit of detection of 10 to 20 copies per reaction.

The testing procedure did not require extraction of the virus from the patient's sample, with the firm developing a proprietary lysis buffer that was used to resuspend patient swab material, while providing biosafety to users.

Exact quantification of biosafety is currently being assessed in an independent Public Health England laboratory.

A fully biosafe process would present additional or novel opportunities and use-cases for point-of-care Covid-19 testing.

Full clinical validation on patient specimens was required for regulatory registration and other emergency listings.

The company said it was “optimistic” that it could be completed successfully, and was targeting CE marking at the end of September or early October, with prospective patient sample collection already underway.

It was targeting initial product launch in Europe.

“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 chief executive officer David Budd.

“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.”

Budd said that, whether in highly-vaccinated countries or not, Covid-19 was likely to be an illness circulating for the long-term, necessitating rapid and accurate testing for infection in a 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.”

At 1031 BST, shares in Genedrive were down 3.11% at 54.5p.