Enabling Global Health Solutions

 

Cepheid’s Global Access Program centers on the belief that everyone, everywhere should have access to high quality diagnostic tests. Together with our partners, Cepheid brings rapid molecular testing to communities in low- and middle-income countries, improving patient outcomes and trailblazing standards of care.

      

Global Tuberculosis Situation

Tuberculosis (TB) is the second leading cause of infectious disease-related death behind COVID-19.1 It is estimated that one quarter of the world’s population is infected with TB2, with the greatest burden falling on low and middle-income countries and poor and marginalized populations. The reservoir of latent disease continues to fuel around 10.6 million cases of active TB disease – 30% of which go undiagnosed – and 1.3 million deaths per year.2

Rapid molecular tests like Xpert® MTB/RIF Ultra are WHO-recommended first-line diagnostic tests for patients with signs and symptoms of TB4

Partnering to End TB by 2030

The opportunity to end TB by 2030 stands before the global community. Along with many other global health care organizations (pharmaceutical companies, NGOs and others), we come together to make up the key components of the WHO's holistic approach in the strategy to End TB. Together, incredible strides have been made against the disease. Learn more about the “unified response from WHO”5

Committed to Delivering MORE Than a Test

Diagnosis is the critical first step in the path to health, linking patients to care, enabling appropriate treatment, and increasing the likelihood of fast recovery. Cepheid’s Global Access Program was established in 2011 to provide equitable access to diagnostic solutions globally through continuous solution innovation, holistic implementation of these solutions, cross-sector partnerships, and advocacy.

Developing innovative solutions to fight TB is in Cepheid’s DNA. In 2006, Cepheid started collaborations to develop a test that could simultaneously detect Mycobacterium tuberculosis and mutations associated with Rifampicin resistance in an easy-to-use workflow. From this, Xpert® MTB/RIF was born. Since then, Cepheid have been continuously innovating to stay ahead of the disease and evolving patient needs.

Results We Deliver

TB MTB XDR Facts

Download the most recent Global Tuberculosis Report published by the World Health Organization

Download

Where We Work

Program History

 

Genexpert System

2006

Cepheid places first GeneXpert® systems

 

WHO launches Stop TB Strategy on World TB Day

world health logo

Cepheid, FIND, University of Medicine and Dentistry of New Jersey (Rutgers University), and NIAID collaborate to develop Xpert® MTB/RIF* for TB with a grant from the Bill & Melinda Gates Foundation

2009 - 2010

Xpert MTB/RIF* launches and gets WHO endorsement

world health logo

Cepheid Global Access

2011

Cepheid officially establishes Global Access Program

In response to high rates of TB-HIV co-infection in Global Access countries, Cepheid and FIND partner on development of Xpert HIV-1viral load* (VL) test.

2014

Xpert® HPV* and Xpert HIV-1 VL* tests launch

2015

Cepheid develops and launches Xpert® Ebola test to respond to West African outbreak with funding support from the Paul G. Allen and Bill & Melinda Gates Foundations

Xpert® HIV-1 Qual* and HCV VL* tests launch

2016

WHO prequalifies Xpert HIV-1 Qual*

world health logo

2017

WHO prequalifies Xpert HCV VL*, Xpert HIV-1 VL*, and Xpert HPV*; Xpert® MTB/RIF Ultra* launches and gets WHO endorsement

world health logo

2020

Xpert® MTB/XDR* launches to detect multidrug-resistant TB with new 10-color multiplexing technology

Xpert® Xpress SARS-CoV-2^ launches

Global Access Program today

  • GeneXpert systems available in multiple modular configuration options
  • 15 tests available under Global Access Program, 7 of which are endorsed or pre-qualified by WHO

How We Work

We embed ourselves in the communities we serve to understand their needs, challenges, and preferences and translate these insights into patient-centric solutions: molecular diagnostic systems, tests, and service and support programs. Diseases are not static, so we continuously challenge ourselves to improve existing offerings and to anticipate what the world will need five to ten years from now.

 

Pushing the envelope for TB diagnostics:

 

With every launch of a new TB test, Cepheid and its partners have redefined how TB is diagnosed and managed. Since 2006, Cepheid has collaborated with Rutgers University, Foundation for Innovative New Diagnostics (FIND), and National Institute of Allergy and Infectious Disease (NIAID) to harness academic discoveries and scale them for real-world use. The Xpert MTB/RIF* test launched in 2010 with funding support from the Bill & Melinda Gates Foundation. It was a first-of-its-kind molecular test, detecting TB and rifampicin resistance simultaneously. In 2017, Xpert MTB/RIF Ultra* improved on the original test by using detection technology that increased analytical sensitivity by 10-fold and improved detection of rifampicin-related mutations. Xpert MTB/XDR* launched in 2020 using new multiplexing technology to detect resistance to six first- and second-line drugs used for TB treatment.

Instruments and tests alone are not enough, so we strive to provide an ecosystem of awareness and educational initiatives, service, support, and delivery models to strengthen national diagnostic infrastructure.

 

Accelerating access to Xpert MTB/RIF Ultra:*

 

Starting in 2017, Cepheid worked with South Africa’s National Health Laboratory System (NHLS) to accelerate access to the new Xpert MTB/RIF Ultra* test. Cepheid’s local Field Application Specialists partnered with the NHLS’ National Priority Programs (NPP) team to make software upgrades required for the test across the instrument network, ensure data transmission into laboratory information systems (LIS) aligned with laboratory requirements, and conduct trainings. The trainings included “train the trainer” sessions for NPP staff, as well as lab employees. In total, Cepheid and NPP employees conducted 70 trainings for more than 200 labs, health centers, and mobile clinics.

We engage directly with donors, policymakers, governments, NGOs, communities, and patients to ensure our work supports global, national, and local health system and disease elimination goals.

 

Responding to the West African Ebola outbreak:

 

When the 2014-2016 Ebola outbreak began in West Africa, lack of rapid accurate diagnostics made it difficult to track the outbreak and implement community health measures. Shortly after the World Health Organization (WHO) declared a Public Health Emergency, Cepheid began development of the Xpert Ebola test with a grant from the Paul G. Allen Family Foundation and the Bill & Melinda Gates Foundation. The first Xpert Ebola tests reached health facilities in June 2015, leveraging the existing GeneXpert systems in Sierra Leone, Guinea, and Liberia. Emergency response teams in the field deployed Xpert Ebola for surveillance and diagnosis, establishing detection centers near zones of transmission to prevent further spread.

We speak up for policies and public health initiatives that increase access to molecular testing and reduce health disparities.

 

Bringing private sector perspective to global disease elimination goals:

 

Cepheid is a member of the Global Fund and Stop TB Partnership Private Sector Constituencies. In these forums, Cepheid advocates for inclusion of high-quality diagnostics and patient-centered care in global disease elimination plans. The Stop TB Partnership Private Sector Constituency has released white papers on topics including connectivity, sustainable investment, and resilient health systems.

To request information on our AccessCare Program please complete the following form:

Access Care

 

Contact Us

 

Resources 

For more information on the Global Access Program and our offerings, please refer to the following:

 

* CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries. Not available in the United States.

^  For use under an Emergency Use Authorization in the United States

IVD. In Vitro Diagnostic Medical Device. May not be available in all countries

1. NPR. Before COVID, TB was the world’s worst pathogen. It’s still a ‘monster’ killer. 13 Feb 2022. Accessed Jun 2022. https://www.npr.org/sections/goatsandsoda/2022/02/13/1079505737/before-covid-tb-was-the-worlds-worst-pathogen-its-still-a-monster-killer

2. CDC. Global TB Overview. March 2024. Accessed May 2024. https://www.who.int/news-room/fact-sheets/detail/tuberculosis

3. WHO. WHO consolidated guidelines on tuberculosis, Module 3: Diagnosis, Rapid diagnostics for tuberculosis detection. 2021. https://www.who.int/publications/i/item/9789240029415

4.  "The END TB Strategy." WHO, Iris.Who.Int/Bitstream/Handle/10665/331326/WHO-HTM-TB-2015.19-eng.Pdf?Sequence=1.

Cepheid is Proud to be Part of Danaher

Danaher’s science and technology leadership puts Cepheid’s solutions at the forefront of the industry, so they can reach more people. Being part of Danaher means we can offer unparalleled breadth and depth of expertise and solutions to our customers.

 

Together with Danaher’s other businesses across Biotechnology, Diagnostics, and Life Sciences, we unlock the transformative potential of cutting-edge science and technology to improve billions of lives every day.