www.fdanews.com/articles/185179-cepheid-achieves-fda-clearance-and-clia-waiver-for-flu-assay
Cepheid Achieves FDA Clearance and CLIA Waiver for Flu Assay
January 11, 2018
California-based molecular diagnostic company Cepheid achieved FDA clearance and a Clinical Laboratory Improvement Amendments waiver for its Xpert Xpress Flu test.
The test is indicated for use in near-patient settings for the detection of Flu A and B RNA.
It can be performed using patients’ nasal swabs in under 20 minutes.