- UK approval granted for COV19-ID test kit
- Fastest test on the market
- Commercial progress outside the UK
Point-of-care molecular diagnostics company Genedrive (GDR:AIM) has received approval from the UK Medicines and Healthcare Products regulatory authority for its COV19-ID kit to be marketed and sold in the UK.
Under CTDA (Coronavirus Test Device Approvals) regulations introduced in July 2021 Genedrive could only sell its testing kit once it received a CTDA. The application was submitted in December 2021.
The company’s testing kit is the fastest point-of-care COVID molecular test on the market. It can deliver positive tests in as fast as 7.5 minutes and negative results in 17 minutes.
Chief executive David Budd commented: ‘The performance of the test has met CTDA standards in all regards, which positions Genedrive well to engage in opportunities as they develop going forwards in the UK.’
The UK COVID market has changed significantly since the government removed free testing, pivoting towards the private sector.
Genedrive believes the transition has created a gap in the market for ‘gold standard’ tests which provide more accurate results than lateral flow test, albeit at higher price points.
The news was well received with the shares gaining 7% to 24.9p.
COMMERCIAL PROGRESS
The COV19-ID test received CE-mark approval on 8 December which meant the product could be marketed across the EU.
The company signed distribution agreements covering Spain, Portugal, Oman, and the United Arab Emirates. The first commercial orders were received in March 2022.
The customer base the distributors are targeting include pharmacies, sports venues and private workplaces where fast and accurate testing provides a significant advantage over lateral flow tests.
Since submitting the test for CTDA approval the company said it had undergone positive external validation and the product claims have been expanded to include the testing of asymptomatic patients.
