On Sept. 29, 2021, Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug Administration for Xpertﾮ Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. The four-in-one test was designed for use on any of Cepheid’s over 26,000 GeneXpertﾮ Systems placed worldwide, with results delivered in approximately 36 minutes.

Cepheid’s previously announced capacity expansion program, supported by parent company Danaher Corporation, was designed in part to address anticipated demand for XpertXpress SARS-CoV-2/Flu/RSV. Cepheid expects the first impact of the program in the fourth quarter of 2020 with additional capacity ramping through 2021.

The new EUA combination test is expected to begin shipping to US customers this week, with expected CE-IVD availability in November.

The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patient in health clinics and nursing homes. At the core of every GeneXpert System is the module (or testing bay) where a test cartridge is loaded onto the machine. Our GeneXpert Systems are configured with a varying number of modules, or test bays, to meet the volume requirements of any setting. Smaller GeneXpert Systems are configured with 2 or 4 modules — meaning up to four different tests can be run at one time. Our largest GeneXpert System is configured with up to 80 modules — meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day.