UK follows EU, U.S. to approve Roche COVID-19 antibody tests
LONDON (Reuters) – Britain is in talks with Swiss drugmaker Roche Holding AG to buy an accurate COVID-19 antibody test, following the lead of the European Union and United States, which had already given preliminary approval to the tests.
Mass antibody testing with millions of kits is being considered by many countries as a way to speed the reopening of economies devastated by the lockdowns and to introduce more tailored social distancing measures.
A Public Health England laboratory concluded on May 7 that the Roche test detected the exact antibodies prompted by the virus, but the findings were only made public late on Wednesday.
“It’s clearly an important breakthrough that we have a test which has been found to be highly specific,” a spokesman for Prime Minister Boris Johnson said, adding that it had “the potential to be a game changer.”
Johnson’s spokesman said there was the possibility of some kind of certificate based on immunity but that scientists still needed a better understanding of immunity to the virus.
The Roche test received a conformity assessment, known as Conformité Européenne, or CE mark, from the European Union on April 28 and received Emergency Use Authorization from the U.S. Food and Drug Administration on May 2.
Roche said it was able to produce hundreds of thousands of the tests per week for the United Kingdom. Germany is getting 3 million of them this month, and 5 million a month after June.
The Daily Telegraph newspaper, which first reported the findings, said the government was in negotiations with Roche to buy millions of kits.
BLOOD TEST
The antibody tests – also known as a serology test – show who has been infected, although it is not yet clear whether the presence of antibodies to the new coronavirus, SARS-CoV-2, confers permanent immunity.
They require a blood test that can be run on fully-automated equipment in laboratories to provide results in just 18 minutes.
Britain’s health ministry did not answer questions about how many tests it would order.
“We are exploring the use of antibody testing across the NHS and ultimately the wider public,” a ministry spokesman said, adding that the government was “actively working on our plans for rolling out antibody testing”.
Similar antibody tests have also been developed by companies including U.S.-based Abbott Laboratories and Italy’s DiaSorin. Abbott and Germany’s Siemens Healthineers have separately laid out plans to produce 20 million tests or more per month for the global market from June.
Based in Basel, Switzerland, Roche said it is ramping up capacity to produce high double-digit millions of tests per month to serve countries accepting the CE mark and the United States.
ILE PHOTO: The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann
Switzerland is nonetheless circumspect about the value of antibody testing in helping craft a strategy to ease restrictions.
Instead, Switzerland is counting on a plan that includes trimming new infections to manageable levels, testing everybody who is symptomatic for active infections, and rigorous contact tracing to find those who may have come into contact with infected individuals.
“The government up to now has not bought any antibody tests,” a Federal Health Ministry spokesman told Reuters. “Their ability to inform us remains simply too uncertain for them to be part of an easing strategy.”
Reporting by Aakriti Bhalla and Aishwarya Nair in Bengaluru, John Miller in Zurich and Liz, Piper, Kate Holton and Guy Faulconbridge in London; Editing by Shailesh Kuber, Philippa Fletcher and Catherine Evans
