Court documents seen by The Independent show the labs are accused of unfairly selecting software that was shown in a test to produce significant numbers of errors and false negatives, samples that should have been positive or classed as needing to be re-taken.
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 of the procurement decision against health secretary Matt Hancock – one of the first court hearings over the procurement processes followed by the government since the start of the pandemic.
The Independent understands lawyers for Diagnostics.ai will accuse the laboratories of choosing a software solution that went on to produce tens of thousands of incorrect results which will have led 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 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.
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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 £1.5million contract in April.
Improvements to the UgenTec system were not made until June – meaning 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 benefitted 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 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 chief executive Steven Verhoeven told The Independent the suggestion its software had made errors was “incorrect”.
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.
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