GeneXpert Infinity-80 Receives FDA Clearance for Use with Xpert Flu Assay

Cepheid announced yesterday that the U.S. Food & Drug Administration (FDA) has cleared its GeneXpert Infinity-80 System, a high-throughput automated molecular system for a wide variety of clinical testing applications. The system has been initially cleared in conjunction with Cepheid’s Xpert Flu test.

The GeneXpert Infinity-80 employs the same module technology that is used across the entire GeneXpert System family and is available in configurations of 16, 24, 32, 40, 48, 56, 64, 72 and 80 modules. In every configuration, the system is designed to adapt to any workflow requirement on-demand, batch, or STAT testing.

"With the capability of generating more than two thousand automated results per day, the GeneXpert Infinity-80 is the most efficient, highest throughput molecular diagnostic system on the market delivered in the same footprint as our current Infinity-48 System," said John Bishop, Cepheid's Chief Executive Officer. "The Infinity-80 also offers a user experience that's generations ahead of alternative solutions enabling true walk-away ease-of-use and minimal hands-on time."

The GeneXpert Infinity-80 System will be available for shipment on July 1st.