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

SUNNYVALE, Calif., — Cepheid (NASDAQ: CPHD) 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. Visit www.cepheid.com for more information on Cepheid’s GeneXpert Systems and growing menu of Xpert tests.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit https://www.cepheid.com.

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