May 13, 2020 / 8:41 PM / 21 days ago

UK follows EU, U.S. in approving 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 have 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 lockdowns and to introduce more tailored social distancing measures.

Tests carried out by Public Health England at Porton Down, a laboratory that provides sensitive and specialist scientific services to the government, concluded on May 7 that the Roche test detected the exact antibodies prompted by the virus. The findings were only made public late on Wednesday.

“This is a good test that will stand us in good stead, moving forwards, and I think it will be incredibly important as the days, weeks and months go by,” said Jonathan Van-Tam, the government’s deputy chief medical officer.

“I anticipate that it will be rapidly rolled out in the days and weeks to come, as soon as it is practical to do so. I also anticipate that the focus will be on the National Health Service and on carers in the first instance,” he told a news briefing.

Van-Tam cautioned, however, that scientists still had limited understanding of whether antibodies provided immunity, to what extent and for how long.

A spokesman for Prime Minister Boris Johnson said the test was an important breakthrough which had the potential to be a game-changer.

The spokesman said there was the possibility of issuing some kind of certificate based on immunity but that scientists still needed to know more about that subject area.

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.

“VERY EXCITING”

Transport Minister Grant Shapps was asked at the government’s daily news briefing whether there was any exclusive deal between Roche and the United Kingdom.

“Of course we’ll want to get as many tests as possible - we’ve never restricted ourselves with that regard,” Shapps said, describing the approval of the Roche test as “very exciting”.

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.

FILE 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, Elizabeth Piper in London; Writing by Guy Faulconbridge and Estelle Shirbon; Editing by Shailesh Kuber, Philippa Fletcher and Catherine Evans

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