Coronavirus: Tens of thousands ‘wrongly given’ all clear by Lighthouse laboratories

Tens of thousands of people infected with coronavirus were incorrectly given the all-clear by England’s Lighthouse laboratories, a High Court trial will be told next week.

Court documents seen by The Independent show that the labs are accused of selecting software that was found in a test to have produced a significant number of errors and false negatives for samples that should have been classed as positive or needing to be retaken.

The two companies behind the Lighthouse labs in England – Medicines Discovery Catapult Ltd and UK Biocentre Ltd – are accused of treating British company Diagnostics.ai unfairly and giving preferential treatment to Belgian company UgenTec, despite the British firm’s software performing better in the test.

The case, first revealed by The Independent in June, also includes a judicial review brought against the health secretary, Matt Hancock, over the procurement decision – one of the first court hearings over the procurement processes followed by the government since the start of the pandemic.

The Independent understands that lawyers for Diagnostics.ai will accuse the laboratories of choosing a software solution that went on to produce tens of thousands of incorrect results, leading to infected people going about their normal lives while at risk of spreading the virus.

Court documents for the trial, which will start on Monday, show that both businesses were given 2,000 samples to analyse in April. The UgenTec software failed to identify three positive samples that were correctly identified by Diagnostics.ai.

UgenTec also failed to identify another 44 tests as positive and separately did not spot a problem in the testing process that would have led to 90 samples being classed as invalid.

The evaluation by UK Biocentre did not address the failures found in the UgenTec system before awarding the company the £1.5m contract in April.

Improvements to the UgenTec system were not made until June, meaning that it operated as it did during the test evaluation for more than two months, with the labs processing tens of thousands of tests every day.

In their defence, the mega-labs do not dispute the number of tests missed by UgenTec but argue they were borderline cases and that Diagnostics.ai had benefited from improving the accuracy of its software.

The court will also hear how staff at the laboratories favoured UgenTec before the decision was made, and gave the company preferential treatment over Diagnostics.ai.

While Diagnostics.ai Ltd’s system has been validated by published clinical research and meets standards set by the National Institute for Health and Care Excellence (Nice), lawyers for the company will say the UgenTec system has not been validated by research and does not meet standards set by Nice.

In June, UgenTec’s chief executive, Steven Verhoeven, told The Independent that the suggestion its software had made errors was “incorrect”, without expanding.

The Department of Health refused to comment on the legal action but said in June that the UgenTec software had been used for several months and was subject to quality assurance processes, though it did not give any further details.

Mr Justice Fraser will hear opening arguments in the case on Monday at the High Court.