NEW YORK – CorDx announced on Thursday that it has submitted its application for the CorDx TyFast Flu A/B & COVID-19 Multiplex Rapid Test to the US Food and Drug Administration for Emergency Use Authorization.
The multiplex lateral flow immunoassay delivers results in 10 minutes from nasal swab samples and distinguishes between COVID-19, influenza A, and influenza B antigens, CorDx said in a statement. The test is designed for use in both point-of-care and over-the-counter settings by healthcare professionals and individuals.
"The introduction of this multiplex rapid test is a critical step forward in our fight against respiratory viral infections," CorDx Founder and CSO Jeff Yufeng Li said in a statement. "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."
The San Diego-based firm previously received EUA for its CorDx COVID-19 Ag Test in November 2022.