Roche: requests FDA approval for new rapid antigen test
(CercleFinance.com) - Roche on Monday asked US health regulators to approve the use of a rapid antigen test designed to help healthcare professionals quickly identify Covid infections, typically in 15 minutes.
The new test uses a nasal swab sample and comes in a small kit that does not require laboratory instruments, so it can be used at various point-of-care locations when healthcare resources are limited, the Swiss drugmaker said.
"The test is highly beneficial where timely decisions are needed and PCR tests are not readily available," Roche noted.
Given the urgency, the company said it expects to have tens of millions of these rapid antigen tests available per month in the United States at launch.
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The new test uses a nasal swab sample and comes in a small kit that does not require laboratory instruments, so it can be used at various point-of-care locations when healthcare resources are limited, the Swiss drugmaker said.
"The test is highly beneficial where timely decisions are needed and PCR tests are not readily available," Roche noted.
Given the urgency, the company said it expects to have tens of millions of these rapid antigen tests available per month in the United States at launch.
Copyright (c) 2021 CercleFinance.com. All rights reserved.