FDA approves marketing application for Xpert Xpress Flu and Xpert Xpress Flu/RSV for influenza-Cepheid

Cepheid announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert Xpress Flu and Xpert Xpress Flu/RSV. Both tests deliver reference-quality molecular results in as little as twenty minutes. The tests are Cepheid's first Xpress branded products � all of which are expected to deliver results in 30 minutes or less.

Xpert Xpress Flu/RSV and Xpert Xpress Flu are twice as fast as their predecessor, Xpert Flu/RSV XC, but have comparable performance characteristics. The new tests feature and share a novel design, which employs multiple targets for each virus. The built-in redundancy results in both high sensitivity and specificity, and reduces the impact of seasonal genomic drift in these viruses that has historically been a problem with molecular tests.