The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is a key pillar of UK tracking and tracking systems, with over 1 billion tests offered to date on contracts worth around £ 3 billion.
As a result, US diagnostics firm Innova recently announced that it will expand its operations in the United Kingdom by opening a plant in Wales that produces millions of LFTs per day.
“The FDA has serious concerns that testing is not well established and presents a risk to health,” he said in a statement released Thursday.
Federal agencies added that some of Innova’s performance claims about the product were not supported by clinical studies.
We have decided not to allow the use of LFT because we are concerned about the risk that the test will result in false positives and false negatives.
The FDA also wrote a warning letter to Innova on April 23 after recalling a product that the company described as the “most serious” type of recall.
The decision comes as a British, putting great pressure on the British government on the heavy use of Innova’s LFT. Medicines and Healthcare Products Regulatory Agency (MHRA) is considering whether to extend the license of the product.
In December, regulators issued a six-month Emergency Use Authorization (EUA) for Innova testing. It will expire on June 22nd.
“Decision [will be] It was considered whether further approvals or amendments to this approval would remain in the interests of health protection, “MHRA wrote to the Department of Health (DHSC).
MHRA Allegedly Concerned about the DHSC move in April, it included Innova’s LFT as part of its mass testing program and called it an EUA-approved “stretch.”
A DHSC spokesman claimed that all tests used as part of the national program “have undergone rigorous clinical evaluation.”
Independent I approached Innova for comment.
The United States warns against the use of certain immunochromatography that the United Kingdom purchases in large quantities
Source link The United States warns against the use of certain immunochromatography that the United Kingdom purchases in large quantities