The following summarises the Company’s response to COVID-19 and the product development of its two SARS-CoV-2 assays.
ON MARKET: Genedrive® 96-SARS-CoV-2 Kit
IN DEVELOPMENT: Genedrive® SARS-CoV-2 ID Kit
REGULATORY - Genedrive® 96-SARS-CoV-2 Kit
The Genedrive® 96-SARS-CoV-2 Kit was submitted for various regulatory approvals as soon as practicable following CE marking, broadly
- CE marked – 22 May 2020
- Applied for FDA emergency use authorisation – June 2020
- Applied for Indian approval - June 2020
- Applied for WHO EUL emergency use listing – June 2020
- Applied for various other in country approvals – June July August 2020
At this moment, we do not have any further indications of timescales from regulatory bodies. We recognise that many are working with large backlogs and large volumes of work.
Genedrive® 96-SARS-CoV-2 Kit
- First commercial sales July 2020 – sales into Europe
- Purchase orders and indicative sales intent of over £1m – subject to regulatory approvals
- Entered collaboration agreement with Beckman Coulter Life Sciences to automate Covid-19 testing – 4 August 2020
- Africa, India and US are primary markets of focus
- We believe there is large international demand in terms of rapid point of care testing.
UK COVID MARKET
- We have registered both the Genedrive® 96-SARS-CoV-2 Kit and Genedrive® SARS-CoV-2 ID Kit with the UK bodies responsible for procuring.
- We believe there is large demand from the UK in terms of affordable point of care testing.
APPLICATIONS - Genedrive® 96-SARS-CoV-2 Kit
- Genedrive provides a freeze-dried test, it does not provide a testing service.
- The test is being sold to professional users via a network of distributors.
APPLICATIONS - Genedrive® SARS-CoV-2 ID Kit
- The Genedrive® solution should be highly desirable based on its underlying characteristics
- PCR proven and validated
- The company’s technical development is on the premise that turnaround times of less than 30 minutes are desirable by end users, and input samples should be easy to obtain from patients (for example, saliva). End features and specifications are subject to achieving technical milestones.