Anchor: Ana Maria Montero
Roche Holding has begun receiving orders for its new COVID-19 antibody test, Chief Executive Officer Severin Schwan said Tuesday, two days after the Swiss company won U.S. approval to deploy the tool.
“Governments are contacting us, our customers are contacting us,” he told CNNMoney Switzerland. “They are pretty impressed by the accuracy of this test and accordingly the demand is very high.”
The Food and Drug Administration on Sunday cleared the test for emergency use in the U.S. and in countries accepting the European Union’s CE mark, which include Switzerland. The company has promised a swift scale-up, with plans to produce tens of millions of tests already this month.
That could add heft to efforts around the world to determine how widely the virus has spread and to identify people who may now be immune. Governments want the information to help them make decisions about phasing out social distancing measures and to revive their moribund economies.
The test looks for telltale antibodies—proteins produced in response to an infection. Because it will be available in large quantities, the test will provide a more granular picture of how the pandemic is evolving, the CEO said in an interview with CNNMoney’s Ana Mario Montero. “If you’re flying blind it’s very difficult to take the right decisions.”
The world has seen the rollout of numerous blood tests for COVID-19 antibodies in recent weeks, but many have proven to be unreliable. Roche says its version is 100 percent accurate at detecting the antibodies and 99.8 percent accurate at ruling out the presence of those antibodies. It runs on high-volume laboratory instruments that are widely used and can churn out as many as 300 results in an hour.
“This is setting new standards and I think it’s a real breakthrough in terms of managing this pandemic,” Schwan said. While scientists haven’t ruled out that a person can get the virus again, he said it’s likely that infection confers immunity.
The CEO said the pandemic has been generally bad for Roche’s diagnostics business because hospitals have been conducting fewer routine tests. The antibody test will help offset the decline, though the effect won’t be material at the group level, Schwan said.
“The margins which we have for this COVID test are comparable to the margins we have for our other tests in our portfolio,” he said. “If I look at the diagnostics business overall, this kind of new coronavirus test will not entirely compensate for the losses and declines we have in the routine testing.”
In the first quarter, the health-care giant benefited from sales of Actemra, an arthritis drug that has shown promise in preventing a potentially fatal immune overreaction in some COVID-19 patients. Large randomized trials are underway, with results due in June.
Edited by Cindy Roberts