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Infection Protection Diagnostics Infectious Disease

COVID-19 Diagnostics Still Not Meeting The Demand

4 years, 3 months ago

14122  0
Posted on Mar 24, 2020, 2 p.m.

Since being given the green light from the FDA only 10 days ago Roche has delivered over 400,000 COVID-19 test kits to over 30 laboratories across the nation, but it could take weeks to months for the industry as a whole to catch up to the widespread testing that is required.

“Demand continues to be much higher than supply,” CEO Severin 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,” Schwan 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.”  

Roche was given the go ahead from the FDA within 24 hours of receiving the application, since that time the FDA has told commercial diagnostic developers they can proceed with their own validated tests and submit an Emergency Use Authorization application within 15 days afterwards. 

The FDA has also granted Thermo Fisher, Hologic, LabCorp, Quidel, Abbot, DiaSorin, GenMark and Primerdesign emergency authorizations, as well as its first point of care COVID-19 test that was developed by Cepheid. 

Even with this it will still take time to build up enough stock to support the widespread screening of all people suspected to be infected, even those who may be asymptomatic, in the ideal approach to help contain the further spread of COVID-19.

“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.” According to international health organizations the number of confirmed cases has more than doubled in the past 4 days. 

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