Since its coronavirus diagnostic received the first emergency green light from the FDA 10 days ago, Roche has delivered over 400,000 kits to laboratories across the U.S.—but CEO Severin Schwan said it could take weeks or even months for the industry as a whole to catch up to the widespread need for testing.
“Demand continues to be much higher than supply,” Schwan said in an interview Monday with CNBC. “The good news is that, in addition over the last week, other companies have received approval for their respective tests. So we are glad that overall capacity is increasing.”
“But the reality is that broad-based testing is not yet possible,” he said. “It’s really of utmost importance to prioritize testing—to focus testing where we can get the highest impact for patients and the healthcare system. That means we have to prioritize high-risk patients and patients with signs and symptoms of the disease.”
The FDA said it granted Roche’s SARS-CoV-2 test an emergency use authorization within 24 hours of receiving the company’s application. Since then, the agency has told commercial diagnostic developers they can proceed with their own validated tests and submit an Emergency Use Authorization application within the 15 days afterward.
Roche said that it began shipping its test kits ahead of the authorization—to have supplies in place once the FDA gave its blessing—to more than 30 geographically strategic labs ready to perform high-throughput testing.
The agency has also granted emergency authorizations to diagnostics from Thermo Fisher, Hologic, LabCorp, Quidel, Quest, Abbott, DiaSorin, GenMark and Primerdesign—as well as its first point-of-care COVID-19 test, developed by Cepheid.
Still, it may take some time to build up enough testing stock to support widespread screening of asymptomatic people—the ideal way to help contain the spread of the coronavirus, Schwan said.
“We’re still a couple of weeks, if not months, out,” he said. “On the one hand, the industry is increasing capacities. But infections are even increasing faster.”
In the U.S., the number of confirmed cases has more than doubled in the past four days. More than 41,000 people had been infected and about 500 had died as of March 23, according to international health organizations.