Press Releases

Cepheid Receives CE-IVD clearance for Xpert HCV VL Fingerstick

Enables Hepatitis C Point-of-Care molecular testing and linkage to care.

SUNNYVALE, CALIF. — September 19, 2018 —  Cepheid today announced the CE-IVD marking of Xpert HCV VL Fingerstick, the first molecular test to detect and quantify hepatitis C Virus (HCV) RNA levels directly from a fingerstick blood sample. Currently, the clinical care pathway for detection of hepatitis C faces many barriers, including complicated multi-step diagnostic algorithms based on antibody screening and RNA confirmation1. These algorithms currently require centralized testing technologies that may result in treatment delays and loss to follow up, and could discourage at-risk populations from accessing testing and receiving care.

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Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu/RSV Test

Respiratory Infection Results in as Little as 20 Minutes1

SUNNYVALE, CALIF. — July 26, 2018 —  Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Xpress Flu/RSV test. The test can be performed in near-patient settings, providing rapid and accurate molecular detection of influenza A and B viruses, and RSV RNA from patient specimens in as little as 20 minutes.1

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Cepheid announces expanded access to Xpert family of virology tests in global regions with the greatest need

SUNNYVALE, CALIF. — July 23, 2018 — Cepheid has announced that under its HBDC Access Program1, the company will immediately lower the price of Xpert® tests used for molecular diagnosis of human immunodeficiency virus (HIV), viral hepatitis (HCV) and human papilloma virus (HPV)2 to US $14.90, to make the tests more accessible to lower-income countries.

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FDA Clears Expanded Claims for ‘Superbug’ Test

Xpert® Carba-R now FDA-cleared to aid clinicians in determining appropriate therapeutic strategy for pure colony specimens

SUNNYVALE, CALIF. — May 15, 2018 — Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, an on-demand
molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative bacteria. The additional claims extend use to analysis of perirectal swab specimens and allow use of Xpert Carba-R test results to guide therapeutic strategies for pure colonies.

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Cepheid Receives FDA Clearance and CLIA Waiver for Xpert Xpress Strep A

Accurate and Reliable Group A Streptococcus Detection in as Little as 18 Minutes1

SUNNYVALE, CALIF. — May 2, 2018 — Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and waiver under the Clinical Laboratory Improvement Amendments (CLIA) for the Xpert® Xpress Strep A test. The test can be performed in near-patient settings by untrained users, to provide rapid and accurate molecular detection of Streptococcus pyogenes (i.e., Group A Strep) in as little as 18 minutes.1

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New IDSA/SHEA Guidelines Highlight Critical Role of PCR Testing in C. difficile Diagnosis

Updated guidelines reaffirm PCR as highly sensitive method for detecting deadly toxigenic C. difficile

SUNNYVALE, CALIF. — February 20, 2018 — Newly released IDSA/SHEA Clinical Practice Guidelines for C. difficile, a major cause of gastrointestinal infection, once again emphasize the need for rapid diagnosis of Clostridium difficile infection (CDI) and the critical role of polymerase chain reaction (PCR) testing methods.

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Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu Test

Flu Results in as Little as 20 Minutes1

SUNNYVALE, CALIF. — January 9, 2018 — Cepheid announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Xpress Flu test. The test can be performed in near-patient
settings, providing rapid and accurate molecular detection of Flu A and B RNA from patient specimens, in as little as 20 minutes.1

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Cepheid Expands Respiratory Disease Portfolio with Xpert Xpress Strep A

Accurate and Reliable Group A Strep Detection in as soon as 18 minutes1

SUNNYVALE, CALIF. — October 5, 2017 — Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Strep A. The test provides rapid, accurate, and reliable molecular detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus or Strep A) DNA from patient throat specimens in as little as 18 minutes for a positive result.

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2017 launch of new TB test Ultra backed by WHO recommendation

Xpert MTB/RIF Ultra can better diagnose TB in children and people living with HIV

Sunnyvale, CA, USA; New Brunswick, NJ, USA; Geneva, Switzerland – 24 March 2017 -- On World TB Day, Cepheid, Rutgers New Jersey Medical School and FIND today announced a new version of the Xpert MTB/RIF test, the Xpert® MTB/RIF Ultra (Ultra), for the diagnosis of TB and rifampicin resistance. The World Health Organization (WHO) earlier today issued a recommendation that Ultra can be used as an alternative to the existing Xpert MTB/RIF test for the diagnosis of TB and detection of rifampicin resistance in all settings1.

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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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