Cepheid's Global Access Program

Global Access

Revolution for
A Better Way

Cepheid’s Global Access program started in 2011 with the vision for equitable access to revolutionary new molecular diagnostics. Today, Cepheid’s Global Access program reaches every corner of the globe impacted by deadly diseases like Tuberculosis (TB), HIV and Ebola.

“Xpert MTB/RIF moved diagnosis from weeks to hours – enabling patients to be treated far more quickly. We have invested heavily in these innovations and will continue to invest in new products critical to eradicating disease.”

David Persing
SVP and Chief Medical
& Technology Officer

Empowering Global Health Solutions

Cepheid’s ongoing commitment to invest and innovate continues to improve the standard of care for communities in low- and middle-income countries. Here is how Cepheid makes a difference:

1

The Innovation Revolution

2

Fostering Partnerships

3

Access and Deployment

1

The Innovation Revolution

Cepheid’s Lab in a Cartridge™ remains a state-of-the-art molecular diagnostics innovation—replacing multiple large laboratory rooms with small cartridge chambers. Cepheid's groundbreaking Xpert MTB/RIF test was the most significant TB diagnostic innovation in nearly a century, and was quickly endorsed by the WHO¹ and heralded by the global community as a game changing diagnostic weapon.

“At a global level, 38% of people newly diagnosed with TB in 2021 were diagnosed with a WHO-recommended diagnostic test, while in 2022, the number rose to 47%. These instruments have been a game-changer.³”

Message from the Executive Director

Global Fund Investments in Health and Laboratory-related Equipment

GeneXpert: Innovation in Action

Learn how Cepheid’s innovative approach dramatically impacts patient care.*

* Not all systems shown available worldwide.

In 2023, Danaher announced that as part of its longstanding efforts to expand access to diagnostic testing, it would provide Cepheid's Xpert® MTB/RIF Ultra diagnostic test cartridges for tuberculosis at cost to the Global Fund to Fight AIDS, TB and Malaria (“Global Fund”) and to less-developed countries eligible for Cepheid's Global Access Program to support greater access to high-quality TB testing – with no profit to Cepheid or Danaher. The company also committed to annually assess the cost of Xpert cartridges using an internationally accredited third party.

The first annual assessment has been completed, and has concluded that there was indeed no profit made.

Providing the Global Fund and partners with TB tests at cost for low- and middle-income countries helps improve the lives of millions of people. We are proud to have played a part in bringing more accurate and affordable tests to the people who need them most. For over 15 years, Cepheid has supported increased testing and expanded access to testing in countries with a high incidence of TB and other infectious diseases. We look forward to continuing our work to achieve more breakthroughs and save more lives.

2

Fostering Partnerships

Cepheid’s technology has played a major role in the foundation of economic recovery across low- and middle-income countries. However, it’s the coordinated efforts of donors, policymakers, governments, NGOs, and national and local health systems that are helping change health initiatives to maximize impact. In fact, a recent health economic analysis found that for every $1 of spend on TB programs the result was $46 in economic impact in country².

“TB is not just a health issue—it is an economic issue, a development issue, and a security issue, and we need strong collaborative efforts from heads of states, private and public sector to really move the needle. We need far more diagnosis, treatment, and prevention. We need more funding, more programs to address barriers to access and more political commitment to help the people who need it most.⁴”

Peter Sands

Executive Director, Global Fund to Fight AIDS, Tuberculosis and Malaria

Making a Difference

"I want to leave a legacy...the children of our children will forget about tuberculosis."

Budi Gunadi Sadikin

Minister of Health

Republic of Indonesia

3

Access and Deployment

With over 20,000 GeneXpert systems installed across HBDC, there isn’t a national algorithm in a high burden country that doesn’t incorporate GeneXpert as the basis of its TB response. In September of 2023, Danaher (Cepheid's parent company) raised the company’s joint commitment to End TB by 2030, delivering all future Xpert MTB Ultra cartridges at cost (no profit). Universally welcomed across National TB Programs globally, this price reduction further expands access to the technology and the overall impact of the Global Access Program.

Program History

2006

Cepheid places first GeneXpert® systems

2006

WHO launches Stop TB Strategy on World TB Day

2006

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

Global Access

2011

Cepheid officially establishes Global Access Program

2006

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

2016

WHO prequalifies Xpert HIV-1 Qual*

2017

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

2020

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

2020

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

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

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

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

Dr. Tereza Kasaeva, Director, Global Tuberculosis Programme, WHO World TB Day 2023, Interview with Dr. Tereza Kasaeva
https://www.youtube.com/watch?v=AL_t8LZkD8Y

1. https://www.who.int/publications/i/item/9789241506335

2. Journal of Benefit-Cost Analysis (2023) https://www.cambridge.org/core/journals/journal-of-benefit-cost-analysis/article/one-million-lives-saved-per-year-a-costbenefit-analysis-of-the-global-plan-to-end-tuberculosis-20232030-and-beyond/A74F0D10F1017092A250EB604ED39B1B

3. Message from the Executive Director: Global Fund Investments in Health and Laboratory-related Equipment; January 21, 2024
https://www.theglobalfund.org/en/oig/updates/2024-01-26-message-executive-director-global-fund-investments-health-laboratory-related-equipment/

4. Peter Sands, Executive Director, Global Fund to Fight AIDS, Tuberculosis and Malaria.
From the TB Innovation Summit https://www.stoptb.org/news/global-health-and-business-leaders-pledge-major-commitments-to-end-tuberculosis

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