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


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

"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 employs the same proven, robust GeneXpert module technology used across the entire GeneXpert System family. The Infinity-80 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.

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

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