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Home » Abbott pushes back on Langone study of ID Now test; FDA cites possibility of swab, transport media issues
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Abbott pushes back on Langone study of ID Now test; FDA cites possibility of swab, transport media issues

May 15, 2020
By Mark McCarty
Abbott Laboratories’ ID Now test for the SARS-CoV-2 virus made waves when it was introduced thanks to the rapid turnaround time the molecular test promised. But questions about the test’s performance have surfaced several times in recent weeks. The latest criticism comes from a study conducted at the New York University Langone Medical Center, which claims the diagnostic compared poorly against a competitor. However, the U.S. FDA said that it has questions about the swabs and transport media used in connection with the test. As a result, it will stand pat regarding the ID Now’s place in the emergency use authorization (EUA) program.
BioWorld MedTech Coronavirus Diagnostics U.S. FDA

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