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FDA Clears Cepheid's GeneXpert Infinity-80 System

NEW YORK (GenomeWeb News) – Cepheid today announced the US Food and Drug Administration has cleared the GeneXpert Infinity-80 System in conjunction with its Xpert Flu test.

The GeneXpert Infinity-80 is a high-throughput, fully automated system designed to deliver around-the-clock results for various clinical testing applications, the Sunnyvale, Calif.-based company said. The system is designed to adapt to any workflow requirement including on-demand, batch, or STAT testing, and is available in configurations of 16, 24, 32, 40, 48, 56, 64, 72, and 80 modules.

"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," Cepheid CEO John Bishop said in a statement. "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."

It will be available for shipment on July 1.

The Xpert Flu assay was originally cleared by FDA in April 2011 to run on the GeneXpert system.

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