CorDx has submitted an Emergency Use Authorization (EUA) application for its CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test to the U.S. Food and Drug Administration (FDA).
The multiplex lateral flow immunoassay is designed to distinguish between COVID-19, influenza A, and influenza B from samples collected using nasal swabs from individuals suspected of having a viral respiratory infection. It delivers results in 10 minutes, CorDx said in a statement.
The test was designed for use in point-of-care settings and for home use; it can be administered by either healthcare professionals or individuals.
CorDx received an EUA for its COVID-19 Ag Test in late 2022.
"The introduction of this multiplex rapid test is a critical step forward in our fight against respiratory viral infections. We’ve received a high volume of calls from across the country expressing interest in us developing this type of multiplex rapid test solution, and we will urgently expand our production lines in Georgia and California to meet this surging demand immediately after FDA’s EUA confirmation,” said Jeff Aiiso Yufeng Li, founder and chief scientific officer of CorDx.
