June 29, 2023

Update (07/11/2023): BD Biosciences responded to the below open letter.

BD Biosciences
2350 Qume Drive
San Jose, CA 95131

To: Tom Polen, Chairman, CEO and President of BD (Becton, Dickinson and Company)


Henok Tilahun, Senior Global Marketing Manager, BD
Caitlin Asjes, Senior Director Global Public Health, BD
Adam Zerda, Senior Director International Affairs, BD
Dr Tedros Adhanom Ghebreyesus and Dr Meg Doherty, WHO
Peter Sands, Global Fund to Fight AIDS, TB, and Malaria
Dr John Nkengasong  and Dr Mamadi Yilla, PEPFAR
Winnie Byanyima and Dr Angeli Achrekar, UNAIDS
Dr Jean Kaseyam and Dr Yenew Kebede Tebeje, African Union and Africa CDC
Mark Suzman and Dr Yogan Pillay, BMGF
Dr Philippe Duneton, Unitaid
Dr Bill Rodriguez, FIND
Nqobile Ndlovu, ASLM


29 June 2023

Open Letter: Urgent action to ensure future access to CD4 diagnostics for people living with HIV

Dear BD representatives,

The undersigned individuals and organizations from communities affected by HIV and working with people living with HIV are writing to express our deep sense of urgency and concern regarding the acute crisis unfolding in the realm of advanced HIV disease/AIDS, specifically concerning the rapidly changing landscape of point of care CD4 instruments.

We are startled and gravely concerned about the Becton Dickinson (BD) November 2022 announcement of its phase-out of its critical CD4 cartridges and FACSPresto and FACSCount instruments by 2024, and to end its service and support for existing CD4 instruments by 2026.

Despite significant progress in the fight against HIV, approximately one-third of all people living with HIV enter care with advanced HIV disease (AHD), and roughly every minute there is another death from AIDS-defining illnesses. Research has demonstrated that relying solely on symptomatic screening for AHD without a CD4 count could miss up to half of the people living with AHD/AIDS. The World Health Organization (WHO), recognizing the importance of CD4 count in assessing an individual’s immune status, guiding clinical management decisions, and evaluating the risk of opportunistic infections, made CD4 cell count the ‘gateway’/surrogate marker to promptly initiate the life-saving AHD package of care.

BD, a self-described leader in “advancing the world of health,” has been instrumental in producing two WHO-prequalified quantitative CD4 diagnostics: FACSPresto6 and FACSCount. Particularly, in low and middle-income countries (LMICs) these instruments are among the “workhorses” used initially to support ART initiation and now diagnose AHD/AIDS which is essential for linking individuals to proper care in a timely manner. The discontinuation of the critical point of care CD4 instruments within the next three years would require countries to fully transition away from BD instruments within that time frame. The decision to phase out these optimal diagnostics from the market could substantially impact timely access to lifesaving AHD package of care and CD4 diagnostics, thereby undermining the global commitment to reduce HIV/AIDS-related deaths to below 250,000 by 2025.

As civil society, community representatives, clinicians, and countries affected by BD’s decision, we are concerned that timely access to AHD care and more specifically CD4 point-of-care instruments and tests hinges on BD correcting its current course of action. We are calling for BD to recommit to supporting the long-term production of point-of-care CD4 instruments and tests and maintaining a sustained supply for LMICs. We strongly urge BD to reconsider its decision to phase out FACSPresto and FACSCount, a decision that directly impacts the health outcomes and quality of life for millions of people globally.

Specifically, we ask BD to:

  • Work with the global community to make the case for better CD4 monitoring: BD and people living with HIV and their allies have a common goal in increasing the use of CD4 monitoring to better detect AHD and link people to life-saving care. Rather than backing away, BD should advocate and bring regular reporting on CD4 procurement and utilization to the effort. One way to help support the global health actors is to conduct an assessment and mapping of the current platforms in an effort to identify those in need of servicing, replacement, or redistribution for AHD.
  • Information on supply and production challenges: We understand that BD claims the discontinuation is linked to supply issues of a specific component(s) that facilitates production. We would like to know the component(s) causing the production challenge and the related supplier information, as well as the steps undertaken by BD with the supplier to address this problem.
  • Provide the minimum threshold needed to sustain production: Given that the need for CD4 tests is estimated to be approximately 8 million according to CHAI10, and the Global Fund to Fight AIDS, TB, and Malaria11 as well as PEPFAR’s renewed support for AHD12, we request BD to reconsider its decision to discontinue the production of FACSPresto and FACSCount instruments and tests.
  • Commit to maintain its production capacity: Should it not reverse course, commitment to continuing production is critical as part of a transition strategy. This is essential to provide countries and donors sufficient time for transition to alternative CD4 testing strategies, thereby ensuring a sustainable continuum of care for individuals living with HIV/AIDS.
  • Commit to continuing services and support: Relatedly, And to commit to providing services and support to existing and new FACSPresto and FACSCount instruments beyond 2026 given countries have invested in these instruments. Additionally, we ask that BD work with national governments, donors, and global health actors to maximize the utilization of existing devices by providing ongoing support, maintenance, and necessary sub-components to ensure uninterrupted access to CD4 diagnostics until replacement diagnostics are available on the market.

We ask that BD provides its responses to the requests above in writing. In addition, we would like to request a meeting with BD’s team at your earliest convenience to discuss this matter.

Thank you for considering this urgent request. We look forward to hearing from you within two weeks of receipt of this letter.



Fight AIDS Coalition (FAC)

Diagnostics Equity Consortium (DEC)

Government and research entities:

Le Centre Régional de Recherche et de Formation à la Prise en Charge Clinique de Fann (CRCF CHU), Sénégal

BC-Centre for Excellence in HIV/AIDS, Canada

City University of New York, Institute for Implementation Science in Population Health, United States

Drugs for Neglected Diseases initiative (DNDi), Switzerland

Institute of HIV Research and Innovation (IHRI), Thailand

Mbarara University of Science and Technology, Uganda

Ministry of Health, AIDS Control Program, Uganda


International and regional organizations:

amfAR – The Foundation for AIDS Research, USA

AIDS Healthcare Foundation (AHF), USA

African Society for Laboratory Medicine (ASLM), South Africa

Asia Pacific Network of People Living with HIV (APN+), Thailand

Aurum Institute, South Africa

Children’s AIDS Fund International, USA

Diagnostics Equity Consortium (DEC), Zimbabwe

Frontline AIDS, South Africa

Global Action For Fungal Infections (GAFFI), Switzerland

The Global Network of People Living with HIV (GNP+), The Netherlands

Health Global Access Project (GAP), USA

International AIDS Society (IAS), Switzerland

International Association of Providers of AIDS Care (IAPAC), USA

International Community of Women Living with HIV Eastern Africa (ICW-EA), Uganda

International Treatment Preparedness Coalition Global (ITPC), South Africa

International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPC-EECA)

International Treatment Preparedness Coalition in Guatemala/Latin America & Caribbean (ITPC-LATCA)

International Community of Women Living with HIV (ICW), Argentina

Journalists Against AIDS (JAAIDS), Nigeria

Médecins Sans Frontières (MSF) Access Campaign, Switzerland

Partners in Health (PIH), USA

Prevention Access Campaign (Global)


National organizations and entities:

Access Care Treatment and Support (ACTS), Ghana

Acción Ciudadana Contra el SIDA (ACCSI), Venezuela

Action Group for Health Human Rights and HIV, Uganda

ADAP Advocacy Association, USA

Advocacy Core Team (ACT), Zimbabwe

Among Karsa, Indonesia

Anantha Network of Positives, India

Andrah Pradesh Drug Users Forum (APDUF), India

Assam Network of Positive People (ANP+), India

Association El Hayet des personnes vivant avec le VIH, Algérie

Association of People Living with HIV (APLHIV) Pakistan, Pakistan

Association of Positive People for Living Excellence, India

Association Tunisienne de Prévention Positive, Tunisie

Bangladesh NGOs Network for Radio and Communication, Bangladesh

Cancer Alliance, South Africa

Chasing Zero, UK

Child Way Uganda, Uganda

Coalition for Health Promotion and Social Development (HEPS), Uganda

Coalition of Women Living with HIV and AIDS (COWLHA), Malawi

Comité de protection des personnes VIH (CPPVIH), Maroc

Community Access National Network, USA

Community Network for Empowerment (CoNE), India

Community of Women Living with HIV Lesotho (ICW Lesotho), Lesotho

Dandora Community AIDS Support Association (DACASA), Kenya

Delhi Network of Positive People (DNP+), India

Dignity and Wellbeing for Women Living with HIV in Tanzania (DWWT), Tanzania

Educating Girls and Young Women for Development (EGYD), Zambia

Ex-Wenela Miners Association of Zimbabwe (EWMAZ), Zimbabwe

Facilitators of Community Transformation (FACT), Malawi

FHI 360, India

Five Horizons Health Services, United States

Gift of Hope Foundation, Tanzania

Global Alliance for Human Rights (GAHR), India

Haryana Drug Users Forum (HDUF), India

Health HIV, USA

Heartland Alliance LTD/GTE (HALG), Nigeria

HIV i-Base, UK

Housing Works, Inc., USA

Initiative for Youth Development Change in Nigeria (IYDCN), Nigeria

Jamaica Community of Positive Women-ICW, Jamaica

Jaringan Indonesia Positif (JIP), Indonesia

Joint Initiatives For Vulnerables Support (Mzeituni), Tanzania

Jointed Hands Welfare Organisation, Zimbabwe

Just Treatment, UK

Kampala District Forum of PLHIV Networks, Uganda

Kamukunji Paralegal Trust (KAPLET), Republic of Kenya

Life Concern, Malawi

Life Health Education Development Foundation Trust, Zimbabwe

Live Alive Network (LIAN), Uganda

Médecins Sans Frontières (MSF) South Africa, South Africa

Meghalaya State Network of Positive People (MSNP+), India

Misbah Society, India

Mozambique Treatment Access Movement (MATRAM), Mozambique

Myanmar Positive Group (National PLHIV Network), Myanmar

NAM aidsmap, United Kingdom

National Coalition for LGBTQ Health, USA

National Councils of People Living with HIV (NACOPHA), Tanzania

National Coalition of People living with HIV in India (NCPI+), India

National Minority AIDS Council (NMAC), USA

The National Organisation for People Living with Hepatitis B (NOPLHB), Uganda

Network in Thane by People living with HIV(NTP+), India

Network of African People Living with HIV West Africa (NAP+WA), Côte d’Ivoire

Om Prakash Network of People Living with HIV/AIDS (OPNP), India

ONG LES Batisseurs, Democratic Republic of the Congo

OurEquity NPC, South Africa

People PLUS, Belarus

Positive Women Network Mizoram (PWNM), India

Positively Aware magazine, USA

Public Citizen, USA

Rainbow Sunrise Mapambazuko, Democratic Republic of Congo

Red Ribbon Istanbul Association, Turkey

South African Health and Technology Advocacy Coalition (SAHTAC), South Africa


Support on AIDS and Life Through Telephone Helpline (SALT), Uganda

Suruwat, Nepal

Swaziland Network of Young Positives (SNYP+), Eswatini

Tabene Youth Advocacy Network, Zambia

Tanzania Community Health and Environment Organization (TACHEO), Tanzania

Tanzania Community Health Information and Support (TaCHIS), Tanzania

Tanzania Community Rights Organisation, Tanzania

Tanzania Health Summit, Tanzania

Tanzania Organisation of Serving Orphans and Vulnerable Children (TOSOVC), Tanzania

Tanzania Network of Women Living with HIV (TNW+), Tanzania

Thai Network of People Living with HIV/AIDS (TNP+), Thailand

Treatment Action Group (TAG), USA

Treatment Advocacy and Literacy Campaign (TALC), Zambia

UK Community Advisory Board (UK-CAB) United Kingdom

Vietnam Network of People living with HIV (VNP+), Vietnam

Vihaan Care and Support Center (CSC), India

Vijana Na Children Foundation (VINACEF Uganda), Uganda

We Rise And Prosper (WRAP), Uganda

Wote Youth Development Projects, Kenya

Youth And Women Emancipation (YAWE), Tanzania

Y+ Global, Tanzania

Y.R. Gaitonde Centre for AIDS Research and Education (YRGCARE), India


Signatures in individual capacities:


Clinicians, professors, researchers, lab and government personnel:

Sunita Agarwalla, Associate Professor, Dispur College, India

Brook K. Baker, Professor, Northeastern U. School of Law, USA

Alexandra Calmy, Head of HIV/AIDS Unit,  University Hospitals of Geneva (HUG), Switzerland

Angelique Corthals, Associate Professor, USA

Masimba Dube, Program Pharmacist, AIDS & TB,  Ministry of Health and Child Care, Zimbabwe

Jayne Ellis, Clinical researcher, London School of Hygiene and Tropical Medicine (LSHTM), Uganda

Eudoxia Filipe, Advanced HIV Disease (AHD) Focal Point, Ministry of Health, Mozambique

Rebecca Gathercole, Global Health Operations Coordinator, St George’s University of London, UK

Deborah Goldstein, Dr., USA

J Carolyn Gomes, The Honourable Dr., Jamaica

Nelesh Govender, Professor, University of the Witwatersrand, South Africa

Leslye Heilig, M.D., USA

Petros Isaakidis, Operational Research Coordinator, Médecins Sans Frontières (MSF), Southern African Nsangi

Laura Joan, Clinical Trials Coordinator,  Infectious Diseases Institute, Uganda

Jessie Kadyevu, Traditional healer, Traditional Medical Practitioner Council, Zimbabwe

Hani Kim, Executive Director, RIGHT foundation, South Korea

David Lawrence, Associate Professor, London School of Hygiene and Tropical Medicine, United Kingdom

Thuy Le, Associate Professor of Medicine, Duke University School of Medicine, USA

Angela Loyse, Senior Lecturer, UK

Marybeth Cherono Maritim, Senior Lecturer and Consultant Physician, University of Nairobi, Kenya

Francois-Xavier Mbopi Keou, Professor of Laboratory Medicine, Infectious Diseases and Global Health, Cameroon

Graeme Meintjes, Professor of Medicine, University of Cape Town, South Africa

Calorine Noel Mekiedje, HIV – TB senior advisor, South Africa

David Meya, Associate Professor,  Infectious Diseases Institute, Makerere University, Uganda

Síle Molloy, Senior Lecturer in Epidemiology, St George’s, University of London (SGUL), United Kingdom

Andrew Mujugira, Senior Research Scientist, The Infectious Diseases Institute Limited, Uganda

Tatu M. Nyange, Lecturer, Mwalimu Nyerere Memorial Academy (MNMA)

Zee Ndlovu, Laboratory advisor, Médecins Sans Frontières (MSF), South Africa

Medical Unit (SAMU), South Africa

Madhukar Pai, Professor of Epidemiology & Global Health, McGill University, Canada

Nitika Pant Pai, Associate Professor, McGill University, Canada

Praphan Phanuphak, Professor Emeritus, Thailand

Stephanie L. Smith, Associate Professor, Virginia Tech, USA

Wendy Stevens, Professor, Wits Diagnostic Innovation Hub, National Priority Program, National Health Laboratory Service, South Africa

Boyer Chammard Timothee, Infectious Diseases Physician, France

Mugabi Timothy, Research Medical Officer, Infectious Diseases Institute, Uganda

Larry Westerman, CDC, USA

Kara Wools-Kaloustian, Director of Research IU Center for Global Health, U.S.A

William Worodria, Physician, Uganda


Civil society individual endorsements:

Ganesh Acharya, TB/HIV Activist, India

Oswald Andrade, India

Anita Autade, Ntp, India

Steven Bamford, UK

Aisuluu Bolotbaeva, Consultant, Kyrgyzstan

Juliet Bosa, United Kingdom

Sanjib Chakraborty, India

Ashmita Chetri, India

Trandan Chutia, India

Mohamed Dadsi, Member CCM/1st Representative of PLwHIV instance de coordination national, Morocco

Naba Kanta Deka, India

Rajesh Didiya, CEO, National TB Network, Nepal

Rajiv Dua, Executive Director, India HIV/AIDS Alliance, India

Rajesh Dutta, India

Maura Elaripe, CCM TB Community Representative, ACT AP, Papua New Guinea

Cindra Feuer, Senior Program Manager, AVAC, USA

Tia Francis, Co-Founder, It’s Possible, USA

Mundrika Gahlot, India

Suparna Gawade, India

Manitosh Ghildiyal, India

Birinchi Gogoi, India

Maurice Greenham, United Kingdom

Amit Singh Gusain, Uttarakhand Association for Positive People Living with HIV/AIDS (UKNP+), India

Haroun Habib, USA

Josephine Ijekhuemen, Executive Director, Center for Rights and Development (CRD)

Jo Josh, UK Community Advisory Board, UK

Kundan Kumar, India

Bandana Kumari, India

Raymond Kwesiga, AFROCAB

Jen Linson, Program Coordinator, USA

Esihle Lupindo, USA

Sharonann Lynch, Associate Director, Global Health Policy and Politics Initiative, O’Neill Institute, USA

Dorina Mathayo, Advocacy Navigator, Advocacy Navigator Program by AVAC

Daisy Montero, USA

Sanjana Mukherjee, Professional Fellow, Global Health Policy, USA

Mercy Nangwale, UK Community Advisory Board (CAB), England

Rahul Narah, Indian

Puneswar Nath, India

Mduduzi Dawood Ngubane, Community Liaison Officer, South Africa

Ambrose Oduch, Chief Representative, Child Way Uganda, Uganda

Faith Onu, Young Persons Network for Sustainable Lifestyle and Health (YOUPEN4SLAH), Nigeria

Peter Owiti, Wote Youth Development Projects CBO, Kenya

Pranjal Pandey, India

Arda Karapınar Panosian, Activist, Türkiye

Fiona Pettitt, United Kingdom

Laltan Puia, Mizoram, India

Vikas Rathod, India

Shekinah Rose, HIV Advocate/Activist, Positively Trans National Advisory Board (NAB), USA

Ankit Sachan, India

Bhaskar Jyoti Saikia, India

Ranjib Saikia, India

Abdul-Fatawu Salifu, Hope For Future Generations (HFFG), Ghana

Fotios Saltaferis, UK

Manisha Salunke, India

Agrata Sharma, Fellow, O’Neill Institute for Global and National Health Law, USA

Archna Sharma, India

Rekha Sharma, India

Subha Sarmah, India

Hari Shankar Singh, India

Richard Stern, Costa Rica

Ch Subbareddy, India

Tracy Swan, Consultant/Activist, Spain

Sahil Tambe, India

Phumeza Tisile, South Africa

Ankita Tiwari, India

Milind V. Rajwade, India

Wim Vandevelde, Liaison Officer, GNP+, South Africa

Sachin Verma, India

Henry Zohmingthanga, India Northeast, Aizawl, Mizoram

Latest publications See All