QuidelOrtho Receives CLIA Waiver For Sofia 2 SARS Antigen+ FIA
Portfolio Pulse from Benzinga Newsdesk
QuidelOrtho Corporation (NASDAQ:QDEL) has been granted a CLIA Waiver from the U.S. Food and Drug Administration (FDA) for its Sofia 2 SARS Antigen+ FIA, a rapid antigen test that detects COVID-19. The waiver means the test is simple and low risk enough to be used in any point-of-care setting equipped with Sofia 2 instruments, without the need for trained clinical laboratory personnel. The Sofia 2 analyzer provides an accurate, objective and automated result in just 10 minutes.

September 21, 2023 | 8:08 pm
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POSITIVE IMPACT
QuidelOrtho's receipt of a CLIA Waiver for its Sofia 2 SARS Antigen+ FIA could potentially increase the company's market share and revenues, as the test can now be used in a wider range of settings. This could have a positive impact on the company's stock price in the short term.
The CLIA Waiver allows QuidelOrtho's Sofia 2 SARS Antigen+ FIA to be used in any point-of-care setting, which could significantly increase the product's market reach and, consequently, the company's revenues. This could lead to a positive impact on the company's stock price in the short term.
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