U.K. Clears Roche Antibody Test in ‘Important Breakthrough’
Roche Holding AG’s coronavirus antibody test was cleared by a U.K. health authority, a boost to relax lockdown restriction
(Bloomberg) -- Roche Holding AG’s coronavirus antibody test was cleared by a U.K. health authority, a development welcomed by Prime Minister Boris Johnson’s office as an “important breakthrough” as his government seeks ways to gradually relax lockdown restrictions.
Public Health England, an executive agency of the Department of Health and Social Care, said the Roche test had been assessed at its Porton Down facility last week and accurately identifies everyone who is over the infection.
The U.K. has faced heavy criticism for its Covid-19 testing regimen, with the country well behind European peers in screening of people showing possible symptoms by using molecular tests that became available in January. The government has also previously bought faulty kits that weren’t effective.
“It’s clearly an important breakthrough,” government spokesman James Slack told reporters on Thursday, echoing Johnson’s past comments that the development of an accurate antibody test could be a “game-changer.” Slack said the U.K. is now in commercial talks with Roche over supplying the tests.
Getting Onstream
Roche’s tool has already garnered praise from U.S. and German officials for its reliability. It could become a useful tool for Johnson, who is seeking ways to get life back to normal as the country faces its most severe economic downturn in centuries.
Antibody tests, when accurate, can show who has already had the virus and may therefore have a degree of immunity, meaning those people can potentially resume social contact with others. However, scientists still aren’t sure whether having antibodies means long-lasting immunity. That’s different from molecular diagnostics, which came out in January and look for the presence of active virus in body fluids such as mucus.
Tests that can reliably identify positive samples -- showing that someone has already been exposed to the virus -- are considered highly sensitive. Tests that can identify negative samples -- showing that someone hasn’t been exposed to it yet -- are called specific.
Roche’s antibody test has demonstrated a specificity of more than 99.8% and a sensitivity of 100%, the company said earlier this month. Specificity is crucial to preventing people from thinking incorrectly that they have built up immunity to the virus.
‘Positive Development’
“This is a very positive development because such a highly specific antibody test is a very reliable marker of past infection,” John Newton, national coordinator of the U.K. Coronavirus Testing Programme, said in an emailed statement. “This in turn may indicate some immunity to future infection, although the extent to which the presence of antibodies indicates immunity remains unclear.”
Roche’s antibody test won emergency use in the U.S. earlier this month and clearance for countries accepting Europe’s CE marking. On May 4, the U.K. government said it was in talks with the company about a mass roll-out of its tests. The Swiss pharmaceutical giant expects production to reach the high double-digit millions by June and pass the 100 million monthly threshold later this year.
“We are working closely with the NHS, public health bodies and the U.K. government to enable the roll out of our test across the U.K. as soon as possible,” Roche said in a statement. “We will be able to provide hundreds of thousands of antibody tests to the U.K. per week.”
As part of its virus response, the U.K. has been increasing its coronavirus testing capacity in recent weeks to more than 100,000 per day, but these are the molecular tests, also called PCR, which only show whether someone currently has the virus.
Underinvestment
Roche CEO Severin Schwan said last month that the U.K. -- and some other countries -- are suffering the consequences of decades of underinvestment in laboratory infrastructure. That’s one reason why the U.K. has struggled to ramp up the molecular testing, while countries including Germany and Switzerland are drawing widespread praise for their regimens.
The situation for antibody tests would be different, Schwan said, because the U.K. and other countries already have a lot of the equipment needed to perform this type of screening in high volumes. Routine blood testing for other conditions has also fallen in the pandemic, freeing up lab capacity for Covid-19 screening.
“This is a completely different magnitude,” Schwan said on the call with reporters. “It’s also easier for us to ramp up production of these systems, so with antibody testing, I’m less concerned.”
Antibody testing is an “important part” of the U.K.’s strategy to better understand how widely Covid-19 has spread and curtail future infections, a DHSC spokesperson said by email.
“We are delighted that devices are progressing through validation, and are actively working on our plans for rolling out antibody testing and will make announcements in due course,” the email said.
©2020 Bloomberg L.P.