Press Releases

Cepheid Announces FDA Clearance Of Xpert® Xpress Flu And Xpert Xpress Flu/RSV

Providing Rapid Molecular Diagnostic Results in as little as 20 minutes

SUNNYVALE, Calif.Feb. 15, 2017 /PRNewswire/ -- Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Flu and Xpert Xpress Flu/RSV. Both tests deliver reference-quality molecular results in as little as twenty minutes. The tests are Cepheid's first Xpress branded products — all of which are expected to deliver results in 30 minutes or less.1

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Cepheid Announces FDA Clearance of Next-Generation Test for MRSA Colonization

SUNNYVALE, Calif.Dec. 19, 2016 /PRNewswire/ -- Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for Xpert® MRSA NxG, the next generation methicillin-resistant Staphylococcus aureus (MRSA) infection control test from the leader in healthcare-associated infection (HAI) testing. Xpert® MRSA NxG is an accurate, on-demand, molecular test that delivers actionable results in about an hour.

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Danaher Completes Acquisition Of Cepheid

WASHINGTONNov. 4, 2016 /PRNewswire/ -- Danaher Corporation (NYSE: DHR) ("Danaher") announced that today it completed its acquisition of Cepheid (NASDAQ: CPHD).

Copper Merger Sub, Inc. ("Copper"), a California corporation and an indirect wholly owned subsidiary of Danaher, has merged into Cepheid and, as a result, Cepheid has become an indirect wholly owned subsidiary of Danaher. In the merger, each outstanding share of Cepheid common stock was cancelled and (except for shares held by Danaher, Copper, Cepheid and their respective subsidiaries) converted into the right to receive $53.00 per share in cash, without interest.

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30 Minute Or Less Molecular Flu/RSV Test Now Available Outside The US

Why Choose Between Fast or Accurate When You Can Have Both?

SUNNYVALE, Calif.Oct. 27, 2016 /PRNewswire/ -- With the flu season fast approaching, healthcare providers no longer need to choose between a fast test result or an accurate test result for patients suspected of influenza infection.  Now, they can have both, with Xpert® Xpress Flu/RSV from Cepheid (Nasdaq: CPHD), a new test that delivers reference-quality molecular test results in as little as twenty minutes.1

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Cepheid Announces Receipt of Required Regulatory Clearances in Proposed Acquisition by Danaher Corporation

SUNNYVALE, Calif.Oct. 24, 2016 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced that antitrust clearances have been received or the requisite waiting periods have expired, as applicable, in the United StatesGermanyAustria and South Africa, which comprise all of the governmental approvals required as a closing condition pursuant to the merger agreement executed in connection with the proposed acquisition of Cepheid by Danaher Corporation.

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New Bladder Cancer Test Could Reduce Number Of Invasive Procedures Required For Recurrence Monitoring

Xpert Bladder Cancer Monitor Now Commercially Available

SUNNYVALE, Calif.Oct. 5, 2016 /PRNewswire/ -- There's now an easier way to confidently rule out bladder cancer recurrence, thanks to a new test from Cepheid (Nasdaq: CPHD), Xpert® Bladder Cancer Monitor, now commercially available in Germany and cleared for commercial availability in all countries accepting the CE Mark. 

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Cepheid Targets Development of a Point of Care HIV Viral Load Test From a Few Drops of Blood

Enabling Accurate and Fast Molecular HIV Viral Load Test from Finger Stick Whole Blood

SUNNYVALE, Calif., Sept. 8, 2016 /PRNewswire/ -- Millions of patients, including newborns, in primary health care settings could gain access to a potentially life-changing test for HIV viral load monitoring thanks to a new development effort from Cepheid (Nasdaq: CPHD), which is being partially funded by a grant from the Bill & Melinda Gates Foundation.

Cepheid's Xpert TV Now Cleared For Testing Symptomatic And Asymptomatic Men

First and Only Trichomonas NAAT Test with Male Urine Claims Cleared for Use in United States

SUNNYVALE, Calif., Sept. 6, 2016 /PRNewswire/ -- Men in the United States can now have easier access to fast and accurate testing for a potentially dangerous sexually transmitted infection, thanks to expanded claims allowed by the Food and Drug Administration (FDA) for the Xpert TV assay by Cepheid (Nasdaq: CPHD), a sensitive urine-based test for Trichomonas vaginalis that delivers results in as little as 35 minutes.

Cepheid Agrees To Be Acquired By Danaher Corporation For $53 Per Share In Cash

SUNNYVALE, Calif., Sept. 6, 2016 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced that it has entered into a definitive agreement with Danaher Corporation (NYSE: DHR) under which Danaher will acquire all of the outstanding shares of Cepheid common stock for $53 per share in cash, or a total enterprise value of approximately $4 billion including indebtedness and net of acquired cash.

Cepheid Reports Second Quarter 2016 Results

SUNNYVALE, Calif., July 28, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today reported revenue for the second quarter of 2016 of $146.0 million, representing growth of 10%, or 12% on a constant currency basis, from $132.5 million for the second quarter of 2015. Net loss was $(10.2) million, or $(0.14) per share, which compares to net loss of $(16.7) million, or $(0.23) per share, in the second quarter of 2015.

Cepheid Announces Results Of Validation Study For Use Of Xpert HPV In Primary Cervical Cancer Screening

Xpert HPV Fulfills International Requirements for Use as Primary Screening Test

SUNNYVALE, Calif., July 12, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced the publication of a validation study assessing the use of Xpert HPV (Human Papillomavirus) as a front-line cervical screening test in certain countries outside the United States. "Performance of a cartridge based assay for the detection of clinically significant HPV infection - lessons from VALGENT (Validation of HPV Genotyping Tests)" has been published on the Journal of Clinical Microbiology website,1 concluding that "the clinical performance and reproducibility of Xpert is comparable to well established HPV assays and fulfills the criteria for use in primary cervical cancer screening."

Opening Of Hammersmith Clinic Furthers The Revolution In Sexual Health Diagnostic Services

Hammersmith Broadway is Next in a Series of Clinics to Offer Fast and Discrete Testing.

SUNNYVALE, Calif., July 5, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today applauded the opening of the 10 Hammersmith Broadway Sexual Health clinic in London, England.

FDA Supports Expanded Claims for Xpert Carba-R Test for "Superbugs"

Xpert Carba-R Test is the First FDA-Cleared Molecular Test for Rapid Detection of Carbapenemase Producing Organisms Directly from Rectal Swab Specimens

SUNNYVALE, Calif., June 30, 2016 /PRNewswire/-- Cepheid (Nasdaq: CPHD) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, the first FDA-cleared test for detection of carbapenem resistance genes of multidrug resistant 'superbugs'. Following initial clearance in March for detection and differentiation of carbapenemase genes in pure bacterial isolates, the latest clearance extends use of the assay to the analysis of direct rectal swab specimens, and positions Xpert Carba-R as a valuable tool for the identification of colonized patients and as an aid to infection control efforts, both of which Cepheid believes are needed to escalate the fight against antimicrobial resistance.

Cepheid Announces World Health Organization Prequalification Of Xpert HIV-1 Qualitative Test

Broadens Access to Critical Diagnostic Results for Infants Born with HIV

SUNNYVALE, Calif., June 15, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that its Xpert® HIV-1 Qual (Qualitative) test has been awarded World Health Organization (WHO) prequalification, making it one of the first molecular point of care tests designed for HIV to be given this designation. The test can detect HIV-1 in whole blood and dried blood spots from individuals suspected of HIV infection, including infants. Inclusion in the prequalification list signifies that Xpert HIV-1 Qual meets WHO's stringent performance, quality, safety and reliability standards, and fulfills a performance measure established for many developing countries and global health participants before they can allow broad deployment of a new technology.

US National TB Controllers Association And Association Of Public Health Laboratories Issue Guidance For Use Of Xpert MTB/RIF To Support Respiratory Isolation Decisions

SUNNYVALE, Calif., May 18, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today welcomed publication of new guidance from the US National Tuberculosis Controllers Association (NTCA) and the Association of Public Health Laboratories (APHL) for users of Xpert MTB/RIF to support decision-making on using Airborne Infection Isolation (AII), commonly referred to as respiratory isolation, in healthcare settings. Cepheid's Xpert MTB/RIF test received FDA clearance for expanded claims relating to respiratory isolation in February 2015, but this is the first formal set of guidelines by NTCA and APHL for users of Xpert MTB/RIF, available at