Two companies are being sued by the UK government for more than £145 million after allegedly supplying faulty COVID-19 tests.
The government told the High Court that the tests “failed at an unacceptable rate”, but the companies deny the accusations and say the tests were effective.
The Department of Health and Social Care (DHSC) is reportedly seeking reimbursement for thousands of COVID tests produced by companies Primer Design Ltd and Novacyt.
The two companies are accused of breaching a contract signed in 2020 due to “unduly high” levels of test failures.
The companies have launched a counterclaim against the government to recover £70 million they say they are owed.
Adam Heppinstall KC, representing the DHSC, told the court that: “The failure rate far exceeds anything that can be tolerated in a product. »
He continued: “Time is of the essence and the quality and robustness of the test is very important. A false negative is frankly very dangerous for public health.
“A test that doesn’t work as often as this test hasn’t worked would slow a lab down to the point of rendering it useless, which in itself poses a threat to public health.”
DHSC signed a contract with the two companies in September 2020, before the second lockdown, and the companies agreed to supply 6,300 COVID ‘Exsig’ kits per week until January 2021, costing the government 145.9 million of pounds sterling before VAT.
Before being distributed to the public, the COVID kits were tested by the Technologies Validation Group (TVG) which identified issues.
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In November 2020, TVG ruled that the tests should not be used and the kits were never rolled out across the NHS.
“Exsig failed at an unacceptable rate due to design and/or manufacturing flaws and therefore lacked robustness,” Mr Heppinstall told the court.
He said Exsig tests were analyzed in seven NHS laboratories, six of which found a failure rate above 10%, with four reporting a failure rate of 25%.
Mr Heppinstall said the testing kits were “unfit for public use”, putting the companies in breach of contract.
In response, the companies launched legal action against the government for £69.7 million and other costs relating to three unpaid invoices.
Their lawyer, Andrew Twigger KC, said in written submissions that the evidence of the test failures was “seriously and patently flawed” and that a trial should be held, and called the government’s claims “completely wrong.”
He said testing of the Exsig kits provided some results that should have been excluded and that a test could fail for “all sorts of reasons.”
“Once these results have been removed from the TVG analysis and the other errors made by TVG corrected, there is no evidence that the sensitivity of the Exsig kits reported by the NHS laboratories which provided information for the TVG validation exercise was less than 100%,” Mr. Twigger said.
He continued: “If not for the errors made by TVG in its evaluation of the laboratory results, the Exsig kits would never have been rejected for sensitivity reasons and this claim would never have been filed in the first place.
“Faced with this difficulty, the government is trying to mount a rearguard action in the form of this assertion of ‘robustness’, which, after analysis, is not tenable.”
The hearing is expected to continue in the High Court.
