The UK Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the Exceptional Use Authorisation (EUA) for Innova’s lateral flow Covid-19 tests after conducting a review.
These tests are indicated for Covid-19 detection in asymptomatic people and can be used for one-off testing before any programme to lower risks and for outbreak testing.
The MHRA review follows the US Food and Drug Administration (FDA) warning last week against the use of Innova’s SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic purposes.
The FDA said that it did not authorise, clear or approve the test for commercial supply or use in the US.
Furthermore, the agency also warned of a health risk as the test’s performance is not adequately assessed.
Innova is the supplier of the National Health Service (NHS) Test and Trace lateral flow devices (LFDs) used as part of the UK government’s asymptomatic testing programme.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData
The Department of Health and Social Care (DHSC) is in charge of legally producing the products used in the UK.
With the latest EUA expansion, the test will be available for use until 28 August.
MHRA devices director Graeme Tunbridge said: “We have now concluded our review of the risk assessment and are satisfied that no further action is necessary or advisable at this time.
“This has allowed us to extend the EUA to allow ongoing supply of these LFDs over the coming months.”
In another development, Zebra Medical Vision has received the UK government’s funding to develop its artificial intelligence (AI)-based osteoporotic fracture prevention model.
The award will offer funds worth £140m over four years to expedite the testing and assessment of AI technologies that meet the aims established in the NHS Long Term Plan.
In partnership with the Royal Osteoporosis Society and the Universities of Oxford and Cambridge, Zebra Medical will utilise the funds to carry out a multi-centre, multi-year study at five NHS sites to evaluate the AI-enabled vertebral fracture pathway.