Cepheid

New rapid molecular test for TB can simultaneously detect resistance to first- and second-line drugs

-- Xpert® MTB/XDR cartridge enables expanded drug-resistance profiling in less than 90 minutes
-- Used to empower clinicians to quickly prescribe treatment regimens for multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), the test could help fill a critical gap that is currently jeopardizing global TB targets

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FIND and Cepheid announce a strategic collaboration to advance point-of-care TB diagnosis

CAPE TOWN, South Africa and GENEVA and SUNNYVALE, Calif., Dec. 3, 2015 -- FIND and Cepheid today announced that they are broadening their collaboration on bringing point-of-care tuberculosis (TB) diagnosis to all levels of the health system in low and middle-income countries (LMICs). The work under the collaboration will focus on evaluating and implementing Cepheid's new GeneXpert® Omni system and Xpert® MTB/RIF Ultra test, in addition to assessing the system's cloud-based connectivity. These efforts will ultimately benefit all stakeholders, as the resulting data and know-how will be made publicly available.

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World's most portable molecular diagnostics system unveiled at AACC

GeneXpert Omni to further decentralize critical TB, virology and Ebola tests.

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Cepheid, FIND & Rutgers announce collaboration for next-generation innovations to game-changing Xpert MTB/RIF test

Xpert MTB/RIF Ultra, the next-generation test for Mycobacterium tuberculosis, will be with increased sensitivity to aid in detection of patients with smear-negative TB, which is often associated with HIV co-infection.

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Cepheid reports China installed base close to 1,000 GeneXpert® systems

SUNNYVALE, Calif., July 29, 2014 /PRNewswire/ -- With the recent completion of a record shipment of 774 GeneXpert systems to a single country in one quarter, Cepheid (Nasdaq: CPHD) today applauded groundbreaking tuberculosis programs in China where more than a million new cases of tuberculosis (TB) are reported each year.  Combined with systems placed previously, the second quarter placements bring the cumulative total of GeneXpert systems in China to more than 970.  The purchase of almost 170,000 Xpert® MTB-RIF cartridges will support the initial roll out of the systems throughout the rest of 2014.

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Cepheid announces Xpert MTB/RIF categorized 'moderate complexity' by FDA

SUNNYVALE, Calif., Aug. 28, 2013 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert® MTB/RIF test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA). Xpert MTB/RIF is designed for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens where MTB-complex DNA is detected, Xpert MTB/RIF also detects rifampin-resistance associated mutations of the rpoB gene.The test runs on Cepheid's GeneXpert® Systems and is the first and only molecular TB (tuberculosis) test to be categorized as Moderately Complex.

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Cepheid receives FDA market authorization for Xpert MTB/RIF

FDA permits marketing of first U.S. test labeled for simultaneous detection of tuberculosis bacteria and resistance to the antibiotic rifampin.

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