NEW YORK ─ Diagnostic test developer Mologic is suing the UK government over the validation of its rapid antigen test for SARS-CoV-2.
The Bedford, UK-based company said its COVID-19 Rapid Antigen Test has performed well in independent studies, but the UK government's facility, where newly developed rapid SARS-CoV-2 tests are validated, has reported 30 to 60 percent failure rates.
Mologic has seen failure rates of less than 2 percent in clinical studies, Joe Fitchett, its medical director, said in an interview. As a result, it wants the UK government to permit an independent observer with diagnostic testing experience to monitor the government's validation process for its test, or for the UK government to greenlight its procurement in the UK.
Mologic has developed a nasal swab test that detects the SARS-CoV-2 nucleoprotein in 20 minutes or less. A person without medical training can run the test at the point of need, including in the home, workplace, education settings, and travel settings, the firm said.
The test has demonstrated high performance in independent clinical studies, including in a recent evaluation for the World Health Organization by the Bill and Melinda Gates Foundation and Geneva-based Foundation for Innovative New Diagnostics. The study found 91 percent sensitivity and 100 percent specificity across 665 participants.
Last December, the company received the CE mark for the test, enabling its use in the European Union and other regions that accept the designation. In preliminary findings in 28 symptomatic patients with PCR-confirmed COVID-19, the test diagnosed infection with a sensitivity of 92 percent and specificity of 100 percent, the firm has said.
However, the UK government's validation reports have restricted its procurement in the UK, Fitchett said.
The UK government's validation for SARS-CoV-2 rapid antigen is conducted at Public Health England's Porton Down site, where investigators and academic collaborators at Oxford University evaluate lateral flow devices referred by the UK Department for Health and Social Care.
A UK Department of Health and Social Care spokesperson told 360Dx that it does not comment on legal proceedings, but that lateral flow testing continues to be a central part of the government's strategy to combat COVID-19. Any lateral flow device it uses to test for COVID-19 must pass a rigorous validation process to make sure it is sufficiently accurate and reliable, the spokesperson said, adding, "Collaboration between industry and government continues to play a central role in our response to this pandemic, and we are hugely grateful to all manufacturers and suppliers who have come forward to offer their assistance in producing lateral flow tests during this unprecedented time."
News of Mologic's lawsuit broke on Monday when The Telegraph reported that the firm sent letters and emails to Prime Minister Boris Johnson, James Bethell, a health minister, and UK members of Parliament, questioning the Porton Down evaluation. Mologic also sent a letter to Public Health England and the UK Department for Health and Social Care asking for their cooperation as an alternative to legal action, but to no avail. As a result, the diagnostic company served court papers on the UK government on Monday.
In contrast to the government testing conducted using contrived samples, other studies to validate its SARS-CoV-2 antigen test used clinical samples, according to Mologic. "We've conducted our own analysis of the results obtained through government testing and other independent clinical studies to validate the test and found that the probability of high failure rates is similar to the chance of being struck by lightning," Fitchett said.
The UK government's testing facility has approved the use of a lateral flow antigen test developed by Innova Medical Group, which has reportedly supplied the UK government with more than 1 billion rapid tests under contracts worth more than £3 billion ($4.23 billion).
The US Food and Drug Administration last week requested that the company stop sales of its Innova SARS-CoV-2 Antigen Rapid Qualitative Test and warned the public against using the test, citing concerns about its performance.
"Because other tests have passed the government's validation, it doesn't mean they are good or that they work," Fitchett said. A case in point is the FDA's decision about Innova's kits, which "are the backbone of the UK's rapid antigen testing strategy," he said.
A BMJ opinion article in January warned that the "UK government is widening the rollout of the Innova lateral flow test without supporting evidence" and called on the government to change its course.
Mologic is also pushing ahead with validation for its antigen test elsewhere. In April, the company announced that the test has been selected for the second phase of the US National Institutes of Health Rapid Acceleration of Diagnostics initiative, involving manufacturing scale-up. The company said it is also seeking US Food and Drug Administration Emergency Use Authorization.
Though the test is being sold throughout Europe, its use has been restricted in the UK as a result of the UK government lab's actions, which is "a waste of taxpayer money," Fitchett said. Mologic developed its SARS-CoV-2 antigen test with almost £1 million in UK government funding.
The UK governments' effort to validate its test has not only been flawed, but may also be redundant, Fitchett said. "My preferred option would be that at this stage in the pandemic, the government's validation of our test using contrived samples in a lab is not needed," he said. "The next best option would be to actually try and understand what went wrong here, because at the moment, what is implied is that it's a problem with the kit, and clearly that's not the problem."