A lateral flow device costing £1.99 per unit has gained regulatory approval for public sale as the end of the UK’s free testing regime approaches.
The COVID assay from Everything Genetic - which reports a clinical performance of 96.1% sensitivity and 100% specificity – has received approval under the UK Health Security Agency’s Medical Devices Regulations 2021 (CTDA).
This permits the healthcare diagnostics business to sell the devices to the UK public, ahead of the government’s end to free testing from 1 April.
Established in 2016, Everything Genetic has a background in genetics testing, but since the pandemic, has provided over a million COVID-19 test kits to help people travel abroad.
James Price, Everything Genetic’s CEO, believes the move from the UKHSA will significantly bring down cost for those worried about having to pay for tests. He hopes the product will come as welcome news to those concerned about the rule change, who might be struggling with a recent increased cost of living.
Price said: "In advance of lateral flow tests kits no longer being provided free by the government, we're delighted our test kits have been granted approval and have met the required Medical Devices Regulations from the DHSC.
“Although COVID tests won't be free after April 1, the importance and demand for using them to accurately gain a rapid insight into our health will continue for some time.
“Our overarching ambition is to democratise testing, whether testing for COVID or genetic cancer or heart diseases. Bringing down the cost-price for these tests to less than a price of a takeaway coffee will help us realise those ambitions and provide customers with access to reliable, accurate and affordable tests.
“It is our first test to be added to the CTDA register and we are already seeing significant demand from our clinical partners and resellers for the product. We anticipate a similar trend will follow from the public, following the Government’s recent announcement to end access to free testing from 1 April.”
Everything Genetic’s nasal-swab kits will be sold as single test kits (priced at £1.99) and will be available in packs of 10’s and 20’s starting at £18.00 and £35.00, respectively.
