The Omega Diagnostics share price surged to close nearly 20 percent higher on the same day that the FDA warned against the use of Innova COVID-19 rapid tests.
With Innova being a major supplier to the UK currently and further establishing presence, the FDA’s request for Innova to stop sales of its SARS-CoV-2 Antigen Rapid Qualitative Test due to concerns over its performance will be greeted well by Omega Diagnostics shareholders.
The US governing body warned the public to refrain from using the respective test for a number of material reasons.
These reasons included that Innova has been distributing the test in the US without approval or authorization, moreover they have been associated as having invalid data on performance.
According to reports, the FDA sent a letter to Innova today to highlight the above and in parallel has requested those who have receipt of the test to return them or dispose of them. This has been classified as class 1 recall by the FDA – the highest of its kind.
This news will likely unsettle the UK government who has spent billions with Innova as it bids to ramp up it domestically developed and produced rapid COVID-19 test plan.
Omega has recently confirmed that it is still awaiting the green light from the government to put a COVID-19 lateral flow test through its production line, however talks are progressing with potential partners (Omega looks to appease shareholders as discussions ongoing with test partners).
The ODX share price is currently at 70p.