EXCLUSIVE: UK follows EU, U.S. with talks on Roche COVID-19 antibody tests
Britain is in talks with Swiss drugmaker Roche Holding AG (ROG.S) 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.
The novel coronavirus, which emerged in China, has propelled the world towards the sharpest recession in centuries with many people isolating at home as governments grapple with one of the biggest public health crises since the 1918 influenza epidemic.
The British government said it was talking with Roche on rolling out its test after a Public Health England laboratory concluded on May 7 that it detected the exact antibodies prompted by the novel coronavirus.
“This has the potential to be a game changer,” Edward Argar, Britain’s junior health minister said on Thursday.
“We are now moving as fast as we can to discuss with Roche purchasing of those but I can’t give you an exact date when we’ll be able to start rolling them out.”
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.
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 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.
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.
Similar antibody tests have also been developed by companies including U.S. based Abbott Laboratories and Italy’s DiaSorin.
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.
“The test requires a blood sample to be taken by a qualified healthcare professional and processed in a laboratory,” Roche said, adding that it was one of the most accurate tests on the market with over 99.8 specificity.
“This level of accuracy is vitally important because there are a number of viruses with very similar antibodies to Covid-19, including the common cold, and other SARS strains, which can produce a positive result in some less accurate antibody tests.”
The Telegraph, which first reported the findings, said the government was in negotiations with Roche to buy millions of kits.