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SARS-CoV-2

Test Information
Woman comforting sick child in bed

Our Mission

Delivering A Better Way to improve patient outcomes by enabling access to molecular diagnostic testing everywhere.

Our Vision

 To be the leading provider of seamlessly connected diagnostic solutions.

 

Associate Promise

Working at Cepheid is MORE than a career.

Explore opportunities to perform groundbreaking work.

Learn more about Cepheid’s Track Record of Innovation.

Cepheid’s Company History

Cepheid was founded in 1996 with a vision to develop an innovative system that simplified a highly complex, multi-stage process for the detection and analysis of nucleic acids, such as DNA, in samples such as blood, urine, food, and industrial water. In its first phase, Cepheid was focused on its SmartCycler® system which integrated the amplification and detection phases of nucleic acid testing in a single instrument. The system was launched in 2000, the same year the Company went public.

The SmartCycler enjoyed broad adoption while the Company began to develop its next platform, the GeneXpert System. Today, the SmartCyler is still used on the U.S. space station.

Cepheid’s Company History

Cepheid was founded in 1996 with a vision to develop an innovative system that simplified a highly complex, multi-stage process for the detection and analysis of nucleic acids, such as DNA, in samples such as blood, urine, food, and industrial water. In its first phase, Cepheid was focused on its SmartCycler® system which integrated the amplification and detection phases of nucleic acid testing in a single instrument. The system was launched in 2000, the same year the Company went public.

 

The GeneXpert System at the Heart of Biohazard Detection

Foreshadowing Cepheid's legacy of quickly developing tests to address urgent public health issues as they emerge, the company’s focus temporarily shifted following the U.S. terrorist attacks in 2001. In collaboration with Northrop Grumman, the GeneXpert system was at the heart of the biohazard detection system for the United States Postal Service. Launched in 2003, the program has delivered over 15 million test results with no false positives. While the biothreat aspect of Cepheid’s business grew, Cepheid quickly returned to its vision of delivering the GeneXpert system, and an associated menu of proprietary tests, to the clinical market.

“Cepheid has a long history of quickly developing and delivering tests that address urgent public health issues as they emerge.”

-David H. Persing, M.D., Ph.D., Cepheid's EVP and Chief Scientific Officer

Cepheid Becomes Trusted Clinical Leader

In 2005, Cepheid officially launched the fully automated GeneXpert system into the clinical market with the release of Xpert® GBS, a test for intrapartum screening of Group B Streptococcus in labor and delivery. Since then, more than 20 US-IVD tests and 30 CE-IVD tests have been introduced — from healthcare-associated infections to women’s health, sexual health, blood virology, and respiratory infections. In 2010, the World Health Organization endorsed Cepheid’s first tuberculosis test, Xpert® MTB/RIF as a game-changer for TB and MDR-TB care delivery, followed by Xpert MTB Ultra.

Cepheid Becomes Trusted Clinical Leader

In 2005, Cepheid officially launched the fully automated GeneXpert system into the clinical market with the release of Xpert® GBS, a test for intrapartum screening of Group B Streptococcus in labor and delivery. Since then, more than 20 US-IVD tests and 30 CE-IVD tests have been introduced — from healthcare-associated infections to women’s health, sexual health, blood virology, and respiratory infections. In 2010, the World Health Organization endorsed Cepheid’s first tuberculosis test, Xpert® MTB/RIF as a game-changer for TB and MDR-TB care delivery, followed by Xpert MTB Ultra.

 

Cepheid Enters the Oncology Market

In 2015, the company announced its intention to develop tests for oncology.  In 2017, Cepheid entered the oncology market with the STRAT4 Breast Cancer test. Today, Cepheid offers diagnostic and/or prognostic tests for breast, prostate, and bladder cancer as well as leukemia.

Cepheid Enters the Oncology Market

In 2015, the company announced its intention to develop tests for oncology.  In 2017, Cepheid entered the oncology market with the STRAT4 Breast Cancer test. Today, Cepheid offers diagnostic and/or prognostic tests for breast, prostate, and bladder cancer as well as leukemia.

 

Cepheid Joins the Danaher Family

Cepheid has United States headquarters in Sunnyvale, California, and European headquarters in Maurens-Scopont, France. The company operates in 17 countries with production sites in the United States, Sweden, and India. Listed on Nasdaq in 2000, Cepheid was acquired in 2016 by Danaher Corporation, a Fortune 150 life science and technology innovator.

Cepheid Joins the Danaher Family

Cepheid has United States headquarters in Sunnyvale, California, and European headquarters in Maurens-Scopont, France. The company operates in 17 countries with production sites in the United States, Sweden, and India. Listed on Nasdaq in 2000, Cepheid was acquired in 2016 by Danaher Corporation, a Fortune 150 life science and technology innovator.

 

Cepheid Leads COVID-19 Pandemic Response

In 2020, after the World Health Organization (WHO) declared a global pandemic in response to SARS-CoV-2, Cepheid rapidly developed and received FDA Emergency Use Authorization for its Xpert® Xpress SARS-CoV-2 test. The company leveraged its global network of GeneXpert systems and provided more than 100 million tests in the fight to slow the spread of COVID-19.

Cepheid Leads COVID-19 Pandemic Response

In 2020, after the World Health Organization (WHO) declared a global pandemic in response to SARS-CoV-2, Cepheid rapidly developed and received FDA Emergency Use Authorization for its Xpert® Xpress SARS-CoV-2 test. The company leveraged its global network of GeneXpert systems and provided more than 100 million tests in the fight to slow the spread of COVID-19.

 

A Track Record of Innovation – Systems

Toggle the button to learn more about Cepheid's systems and tests.

2000

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SmartCycler

Integrated amplification and detection

Smart Cycler System

2005

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GeneXpert System

Integrated sample preparation, amplification, and detection. Available in multiple modular configurations

GeneXpert System

2009

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GeneXpert Infinity-48 System

Even greater automation with up to 48 modules

GeneXpert Infinity-48 System

2011

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GeneXpert Infinity-80 System

With up to 80 modules and continuous automated operation

GeneXpert Infinity-80 System

2016

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GeneXpert System Milestone

10,000th GeneXpert system delivered to 10 Hammersmith Broadway in London, UK

GeneXpert System

2017

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GeneXpert Xpress

System for near-patient applications in CLIA waived settings

GeneXpert Xpress

2019

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GeneXpert Edge

For use by health services with limited infrastructure

GeneXpert Edge

A Track Record of Innovation – Tests

2004

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Anthrax Cartridge

Integrated sample preparation, amplification, and detection for deployment in U.S. Postal Service sorting offices

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2005

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First Clinical Xpert Test

Xpert GBS was Cepheid’s first clinical test, launched for Group B Streptococcus detection in labor and delivery

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2007

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Xpert MRSA Surveillance cleared by FDA

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2010

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Xpert MTB/RIF

WHO endorsement through the Global Access Program to help fight tuberculosis around the world

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2013

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Xpert CT/NG

Launched in the U.S., Cepheid's initial entry into high-volume testing markets

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2014

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Xpert HIV-1 Viral Load CE

Cepheid enters virology testing

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2017

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Xpert Breast Cancer STRAT4

Cepheid enters the oncology market

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2018

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Xpert HCV VL Fingerstick

First molecular test to detect HCV RNA levels directly from a fingerstick of blood

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2020

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Xpert Xpress SARS-CoV-2

Receives Emergency Use Authorization in rapid response to the COVID-19 pandemic

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2021

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Xpert Xpress SARS-CoV-2/Flu/RSV

For detection and differentiation of SARS-CoV02, Flu A, Flu B, and RSV

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