A government health watchdog is considering legal action against a private health company whose laboratory gave at least 43,000 people potentially false negative Covid-19 test results.
The UK Health Security Agency (UKHSA), the successor body to Public Health England, had already commissioned an independent quality audit of work at the Wolverhampton site of Immensa.
Subsequently, the UKHSA refused a freedom of information request from the Good Law Project to give details of the audit and who carried it out, citing legal issues.
The agency said it was declining to release the information on public interest grounds “on the basis of either or both legal advice and/or litigation privilege”.
The response to the Good Law Project, seen by the Guardian, added: “This does not confirm that UKHSA will formally litigate under the contract at this time but allows UKHSA time to investigate in full before determining its final position under this contract, as well as to follow the legal advice that it has received.”
Good Law Project has said it plans to challenge the freedom of information decision, saying it believes the audit was carried out months ago, before revelations about apparent failures at the Wolverhampton lab.
NHS test and trace suspended testing operations by Immensa in Wolverhampton in October after an investigation into reports of people receiving negative PCR test results after they had previously tested positive on a lateral flow device.
Test and trace said about 400,000 samples had been processed through the lab, the vast majority of which were negative results, but an estimated 43,000 people may have been given incorrect negative PCR test results, mostly in south-west England.
Later that month it emerged that the Wolverhampton laboratory was continuing to process results for international travellers who bought tests through its sister company, Dante Labs, and that an employee from the joint company was supporting test and trace “in a technical role”.
The Dante Labs website shows it still offers travel-type PCR tests for sale, although all of them are currently listed as out of stock. The website says it had “temporarily suspended the sales of antigen lateral flow tests”.
Companies House records show Immensa was formed in May 2020, and is run and wholly owned by Andrea Riposati, chief executive of Dante Labs.
A UKHSA spokesperson said: “A full investigation into the Immensa laboratory remains ongoing and we will provide an update in due course.”
Jo Maugham, director of the Good Law Project, said: “We welcome, of course, any legal action government brings against Immensa. But Immensa’s failures are the consequence of government’s inexplicable decision to give £119m in public funds, without competition, to an unaccredited, box-fresh testing outfit. Government has very real questions to answer and – for the communities that were betrayed – we mean to ask them.”
Immensa and Dante Labs were contacted for comment.