May 3, 2020
Roche's COVID-19 antibody test approved by U.S. FDA for emergency use
Canada's 'economy won't go back to normal' until we have a vaccine for COVID-19: Rosenberg
Roche Holding AG received emergency-use authorization from the U.S. Food and Drug Administration for its new test determining if someone has been exposed to COVID-19, according to a statement on Sunday.
The Basel-based drugmaker said it has already started shipments and that as of May, tens of millions of the antibody test will be available in the U.S. and much of Europe.
Governments are trying to learn how many people have been exposed to the coronavirus as they wind down social-distancing measures. The restrictions on businesses have cost millions their jobs and the global economy is on course for its deepest dive since the Great Depression.
“Our best scientists have worked 24/7 over the last few weeks and months,” said Thomas Schinecker, chief executive officer of Roche Diagnostics.
Hospitals and reference laboratories can run the Elecsys Anti-SARS-CoV-2 test on one of Roche’s analysis platforms, the Swiss pharmaceutical company said.
Roche’s antibody test has a specificity of more than 99.8 per cent and 100 per cent sensitivity, meaning that it not only reliably identifies patients who’ve developed antibodies but also can filter out those who haven’t, reducing misdiagnoses.
With no vaccine available yet for the novel coronavirus, there have been proposals that people who have antibodies could be issued an “immunity passport” that would allow them to travel or return to work, on the assumption that they were safe from re-infection.
Yet the World Health Organization has cautioned on the level of protection against a second infection that people who have recovered from Covid-19 will have.
Once any resistance to the coronavirus is better understood, the new test could help to assess who has built up immunity, Roche said.
In addition to the search for a vaccine, more than 100 different programs have been launched to develop and test treatments. These include everything from antiviral drugs and antibody-containing plasma from recovered patients, to traditional Chinese herbal medicine.
Gilead Sciences Inc.’s antiviral drug remdesivir has been cleared by U.S. regulators for emergency use in COVID-19 patients, becoming the first medication backed by early clinical data to be made available to fight the disease.
--With assistance from Tim Loh.