Press Releases

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 http://www.tbcontrollers.org/resources/airborne-infection-isolation/#.VzDVXKV0wbw.

Cepheid Reports First Quarter 2016 Results

SUNNYVALE, Calif., April 28, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today reported revenue for the first quarter of 2016 of $144.8 million, representing growth of 9%, or 13% on a constant currency basis, from $132.6 million for the first quarter of 2015. Net loss was $(6.6) million, or $(0.09) per share, which compares to net income of $0.9 million, or $0.01 per share, in the first quarter of 2015.

Cepheid Announces Partner Distribution Agreement With Medline

Further Broadens Reach of GeneXpert System into Non-Acute Market in United States

SUNNYVALE, Calif., April 21, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced an agreement with Medline, the largest privately held distributor of healthcare products in the United States, for the distribution of the GeneXpert® System and menu of Xpert® tests spanning healthcare associated infections, critical infectious disease, and sexual health. Under the terms of the non-exclusive agreement, Medline will begin offering the GeneXpert System to non-acute care laboratory customers in the United States, including long-term care facilities with moderately complex labs, physician-office laboratories, women's health and large multi-specialty clinics, urgent care facilities, community health centers, correctional facility laboratories, student health centers, STD clinics, and reference laboratories.

Using 'Diagnostics First' Could Help Preserve Effectiveness Of Life-Saving Antibiotics

Cepheid Highlights Role of Diagnostics as Valuable Tool in Growing Fight Against Antibiotic Resistance

SUNNYVALE, Calif. and AMSTERDAM, April 11, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced the launch of its 'Diagnostics First' campaign to raise awareness for the use of accurate and fast diagnostic tests to inform optimal treatment decisions and avoid over-prescription of the world's limited arsenal of antibiotics.

Cepheid Announces European Approval Of Xpert MRSA Next Generation (NxG) Screening Test

The Number One, On-Demand Molecular Test for MRSA Colonization is Now Improved

SUNNYVALE, Calif., March 29, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced commercial availability, outside the United States, of Xpert® MRSA NxG, a next generation version of the market-leading molecular diagnostic test for Methicillin-Resistant Staphyloccus aureus (MRSA). Xpert MRSA NxG has been updated to identify mecA- and mecCcontaining MRSA strains and detect new and emerging SCCmec subtypes with enhanced performance. The assay has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices. Xpert MRSA NxG is an important update to the menu of 23 tests available internationally to run on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with over 10,000 systems deployed globally in both developed and emerging market countries.

Cepheid Recognizes World TB Day 2016 With Delivery Of 5,000th GeneXpert System To Support Global Fight Against Tuberculosis And Multi-Drug Resistant Tuberculosis

SUNNYVALE, Calif., March 24, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today recognized World TB Day 2016 with the delivery of the 5,000th GeneXpert® System to be deployed as part of the company's shared commitment, with partners including the Foundation for Innovative New Diagnostics (FIND) and USAID, to enable global access to industry-leading and potentially life-saving information from molecular diagnostic tests to patients regardless of geographic location.

Cepheid Announces First FDA-Cleared Test for Detection of Carbapenem Resistance Genes in Isolates of Multidrug Resistant 'Superbugs'

Xpert Carba-R Results in Less Than an Hour Help to Prevent and Manage Outbreaks

SUNNYVALE, Calif., March 9, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Carba-R, a qualitative in vitro diagnostic test for fast, accurate, and reproducible identification of 5 distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including KPC, NDM, VIM, OXA-48 and IMP. Xpert Carba- R is the first FDA-cleared test for detection and differentiation of carbapenemase genes in pure bacterial isolates, previously shown to be non-susceptible to carbapenem antibiotics, which may be cultured from a wide range of clinical specimens, including blood cultures, urine, respiratory samples, abscesses and swab surveillance specimens.

Cepheid Delivers Milestone 10,000th GeneXpert System

Dean Street Express Expanding to Additional Locations using GeneXpert Infinity System

SUNNYVALE, Calif., March 7, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced the delivery of the 10,000th GeneXpert® System to the 10 Hammersmith Broadway Clinic in London, England.

Cepheid Announces Appointment of President and Chief Operating Officer and Welcomes Executive Vice President of Engineering and Operations

SUNNYVALE, Calif., Feb. 10, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that Warren Kocmond, formerly Executive Vice President and Chief Operating Officer, has been promoted to the position of President and Chief Operating Officer. In his new capacity, Mr. Kocmond's responsibilities have been expanded, and now include Global Commercial Operations in addition to Manufacturing Operations, Engineering, Technical Service and Customer Service. Mr. Kocmond will continue to report to John Bishop, Cepheid's Chairman and Chief Executive Officer.

Cepheid Reports Fourth Quarter And Full Year 2015 Results

Commercial Clinical Grew 19%, or 21% in Constant Currency, Driven by Record Reagent Revenue and Record GeneXpert System Placements

SUNNYVALE, Calif., Feb. 2, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today reported revenue for the fourth quarter of 2015 of $147.0 million, representing growth of 12% from $131.5 million for the fourth quarter of 2014. Net loss was $(9.8) million, or $(0.14) per share, which compares to net loss of $(23.8) million, or $(0.34) per share, in the fourth quarter of 2014.

Cepheid Announces Diagnostic Collaboration With MedImmune And COMBACTE To Facilitate Clinical Trials Of New Monoclonal Antibodies To Prevent Serious Infectious Diseases

GeneXpert Systems and Xpert Tests Expected to Enhance Efficiency of Clinical Trials

SUNNYVALE, Calif., Jan. 13, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced a collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, and COMBACTE, a European public/private partnership set up to promote the development of new drugs in the anti-infectives field, to develop a series of rapid diagnostic tests to identify Staphylococcus aureus (S. aureus) and Pseudomonas aeruginosa (P. aeruginosa) in respiratory secretions of mechanically ventilated patients. These tests will be used to help identify patients for MedImmune's MEDI4893 and MEDI3902 clinical programs, which are being conducted within the COMBACTE consortium to explore the use of biologics in preventing ventilator associated pneumonia (VAP) infections in intensive-care-unit (ICU) patients.