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Mon 6 December 2021

A firm that has been contracted to supply more than £2.3 billion worth of tests to the UK has been accused of several violations in America by the FDA

An American company that has provided billions of pounds worth of COVID-19 tests to the UK has been accused of multiple violations in the US by the Food and Drug Administration (FDA).

In a warning letter to the firm, the FDA accused Innova of distributing COVID-19 rapid antigen tests in the US without approval and of using false data that inflates their performance.

Innova has won contracts worth at least £2.3 billion for the supply of rapid antigen tests, otherwise known as ‘lateral flow’ tests, from the UK Government – the largest supplier of these devices to the UK, by Byline Times’ calculations.

The FDA conducted an inspection of Innova’s facility in Pasadena, California, between 15 March and 9 April this year – finding several violations of its regulations.

Notably, the FDA found that the Innova antigen rapid qualitative test has “been distributed in the United States without marketing approval, clearance, or authorisation from FDA”.

Consequently, the federal agency has ordered Innova to immediately “cease the sale and distribution of such unapproved, uncleared, and unauthorised products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19”.

The FDA also claims that labels used on Innova devices were “false or misleading” as they do not “accurately reflect the performance estimates observed during the clinical studies of [the] devices”. According to the regulator, the labels boasted of clinical performance that “appears unsupported” – both in terms of data submitted to the FDA and published reports of clinical studies into the Innova test.

“The data reliability and accuracy issues noted herein raise significant concerns that the performance of the SARS-CoV-2 Antigen Rapid Qualitative Test has not been adequately established, and that the products distributed by Innova without FDA approval, clearance, or authorisation could present a serious risk to the public health,” the FDA states.

The inspection also found that the “methods used in, or the facilities or controls used for… manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements”.

For example, the FDA suggests that Innova failed to check certain tests that were provided by a manufacturer in China, consequently meaning that devices were “shipped to customers with the incorrect ‘Instructions for Use’”. The FDA notes that Innova put in place new checking systems and “completed personnel training on the new procedures and work instructions,” after this error was identified.

However, despite this, the FDA says that Innova “has not established” adequate procedures “for implementing and documenting corrective and preventive action”.

The firm has been ordered to promptly fix these problems. In the meantime, American consumers will be advised “not to purchase or use certain products that are not in compliance with FDA requirements and are being misleadingly represented as safe”.

The FDA has invited Innova to respond to its claims, if it believes any of them are unjustified. A statement has not yet been made by the company. Byline Times has approached Innova for comment.


Moonshot

There has been some controversy in the UK about the labelling of Innova tests. It was reported in January that the Department of Health and Social Care (DHSC) was repackaging the Innova lateral flow tests, to remove labels suggesting that the devices are only for professional use for people with COVID-19 symptoms. The Government instead sought to brand them as self-tests that should be used on people without symptoms.

According to report, the manufacturer insisted that the tests are only intended for use by trained laboratory personnel. The rebranding exercise was reportedly designed to gain approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the most flexible use of the devices as quickly as possible.

There has also been some dispute about the efficacy of lateral flow tests more generally. As highlighted by Birmingham University biostatistics professor Jon Deeks, Government statistics show that, in Liverpool, lateral flow tests picked up just 50% of positive cases identified by the ‘gold standard’ (and slower) PCR tests. What’s more, 30% of high-viral-load cases were missed by the rapid tests.

The Government, however, has repeatedly defended the efficacy of lateral flow tests, launching a new campaign in April encouraging people to get tested for COVID-19 twice a week, using rapid devices. In March, it claimed that new analysis showed that lateral flow tests “have a specificity of at least 99.9% when used to test in the community”.

“The Innova test has already gone through the UK’s rigorous Porton Down assessment process, and we have a robust quality assurance process in place,” a DHSC spokesperson said. “We have confidence in lateral flow tests, which help us identify people without symptoms but who could pass the virus to others – helping break the chains of transmission.”

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