<\/p>\n
Mr. Warren C. Kocmond
\nPresident and Chief Operating Officer
\nCepheid
\n904 Caribbean Drive
\nSunnyvale, CA 94089
\nUnited States<\/p>\n
CC:
\nMr. Philippe Jacon, President, Global Access, Cepheid
\nMr. Peter Sands, Global Fund to Fight AIDS, TB, and Malaria
\nDr. Tedros Adhanom Ghebreyesus, World Health Organization
\nDr. Catharina Boehme, FIND
\nDr. Philippe Duneton, Unitaid
\nMr. Ira Magaziner, CHAI
\nMs. Etleva Kadilli, UNICEF
\nDr. Olusoji Adeyi, World Bank
\nDr. Emilio Emini, Bill & Melinda Gates Foundation
\nDr. John Nkengasong, Africa CDC
\nDr. Benjamin Djoudalbaye, African Union
\nMr. Nqobile Ndlovu, African Society for Laboratory Medicine
\nHonorable Zweli Mkhize, National Department of Health, South Africa
\nHonorable Rajesh Bhushan, Ministry of Health and Family Welfare, India
\nHonorable Eduardo Pazuello, Ministry of Health, Brazil
\nHonorable Mutahi Kagwe, Ministry of Health, Kenya
\nMr. Balram Bhargava, Indian Council of Medical Research
\nDr. Jarbas Barbosa, PAHO
\nMs. Gloria D. Steele, USAID
\nGlobal Fund Members of the Board
\nUnitaid Members of the Board
\nACT-A Facilitation Council Members
\nACT-A Diagnostics Pillar and Diagnostics Consortium Members
\nIntegrated Diagnostics Consortium Members<\/p>\n
25 February 2021<\/p>\n
Dear Mr. Kocmond,
\nThe world is grappling with not only a devastating global COVID-19 pandemic but also inadequate access to affordable medical tools, including diagnostics. The 108 civil society organizations below are writing out of deep concern about the lack of access to Cepheid\u2019s GeneXpert SARS-CoV-2 tests in low- and middle-income countries (LMICs).<\/p>\n
We are writing to request that Cepheid increase access to these tests by committing a greater proportion of its COVID-19 manufacturing capacity to LMICs and by lowering the price of its cartridges.<\/p>\n
The COVID-19 Supply Chain System and Diagnostics Consortium was established in February 2020 at the request of the United Nations Secretary-General and the World Health Organization Director-General. The consortium, comprised of international public health and procurement agencies, works to secure adequate supply volumes and affordable prices of COVID-19 diagnostics for LMICs. It also coordinates procurement and equitable allocations across countries. We understand that Cepheid will again be asked by the Consortium to commit adequate volumes at an affordable price for LMICs for the next tranche of supply starting March 2021.<\/p>\n
While wealthy nations have numerous options in terms of quality-assured COVID-19 reverse transcription-polymerase chain reaction (RT-PCR) testing assays to perform on a variety of platforms and instruments, Cepheid\u2019s GeneXpert SARS-CoV-2 test is critical for LMICs given the existing placement of Cepheid\u2019s GeneXpert instruments in these countries.<\/p>\n
We are disappointed, therefore, that Cepheid has continued to undersupply LMICs through the Diagnostics Consortium. According to the latest COVID-19 Supply Chain System situation report (dated 25 January 2021),1 Cepheid committed only two million COVID-19 tests over the last six months. In contrast, Cepheid sold nine million COVID-19 cartridges globally in the fourth quarter of 2020.2 It is shameful that less than 15% of Cepheid\u2019s total production capacity is committed to the Diagnostics Consortium, which represents 144 low- and middle-income countries accounting for more than 80% of the global population. We urge Cepheid to commit greater volumes to the Diagnostics Consortium.<\/p>\n
We also request a significant reduction of the price per GeneXpert SARS-CoV-2 cartridge for all LMICs from the current US$19.80 down to $5 per cartridge, based on available evidence that it costs Cepheid less than $5 to produce the GeneXpert cartridges at volumes over 10 million annually.3 Based on the fact that Cepheid\u2019s global annual sales volume in 2021 will likely exceed 36 million COVID-19 tests,2 in addition to sales volumes for other diseases, a price reduction is
\nlong overdue. Such a price reduction would also better reflect the $4.7 million in public financial contributions from the U.S. government that went into the development of the GeneXpert SARSCoV- 2 tests.4<\/p>\n
Cepheid surpassed $2 billion in annual revenue in 2020,2 representing 100% growth over the previous year, largely through sales of the SARS-CoV-2 GeneXpert tests. Given this and the 35% increase in instrument sales during 2020 from the previous year, countries\u2019 efforts to address the COVID-19 pandemic have more than helped recoup Cepheid\u2019s initial investments and start-up costs for the SARS-CoV-2 tests.<\/p>\n
Too many countries that invested in Cepheid\u2019s instruments to address tuberculosis, HIV, and COVID-19 now cannot procure the necessary COVID-19 cartridges due to Cepheid\u2019s consistent undersupply of the Diagnostics Consortium. Cepheid should take urgent steps in the global fight against the COVID-19 pandemic by committing to supply the volumes requested through the Diagnostics Consortium and decreasing the price of its GeneXpert SARS-CoV-2 test to $5 per cartridge. Furthermore, we would like to reiterate previous appeals from civil society and affected communities to Cepheid to decrease the price of its other GeneXpert tests, including for tuberculosis, HIV, HBV, and HCV, to $5, inclusive of service and maintenance.5 This price better3 reflects the cost of manufacturing and would allow LMICs to scale up GeneXpert testing for COVID-19 as well as other infectious diseases, and therefore save lives.<\/p>\n
We look forward to Cepheid\u2019s response to this letter by Thursday, 11 March, which should be directed to david.branigan@treatmentactiongroup.org.<\/p>\n
Sincerely,
\nAction Canada for Sexual Health and Rights, Canada
\nAIDS Access Foundation, Thailand
\nAIDS Action Baltimore, United States
\nAIDS and Rights Alliance for Southern Africa (ARASA), Namibia
\nAlliance for Public Health, Ukraine
\nAmericas TB Coalition, United States
\nAPCASO, Asia-Pacific
\nAPLA, United States
\nAsha Parivar, India
\nAsia Pacific Network of People Living with HIV (APN+), Asia Pacific
\nAssociation Nationale de Soutien aux Seropositifs et Malades du Suda, Burundi
\nAU-ECOSOCC Kenya National Chapter, Kenya
\nCanadian Aboriginal AIDS Network, Canada
\nCanadian AIDS Society\/Soci\u00e9t\u00e9 canadienne du sida, Canada
\nCancer Alliance, South Africa
\nCarmelo Hospital of Chokwe, Mozambique
\nCENTA, Tanzania
\nCHISA, Malawi
\nCitizen News Service (CNS), India
\nCoalici\u00f3n TB de las Americas, Uruguay
\nCoalition des organismes communautaires qu\u00e9b\u00e9cois de lutte contre le sida (COCQ-SIDA),
\nCanada
\nCoalition of People Fighting HIV\/TB in Migori (COPFAM), Kenya
\nCoalition PLUS, Global
\nCommunity and Family Aid Foundation, Ghana
\nCultura LLC, United States
\nDelhi Network of Positive People (DNP+), India
\nDisabled and HIV\/AIDS Organization Lesotho (DHAOL), Lesotho
\nDr Uzo Adirieje Foundation (DUZAFOUND), Nigeria
\nEMPOWER INDIA, India
\nEnd Hep C SF, United States
\nEuropean AIDS Treatment Group (EATG), Belgium
\nFundaci\u00f3n Grupo Efecto Positivo, Argentina
\nFundaci\u00f3n IFARMA, Colombia
\nFundamental Human Rights & Rural Development Association (FHRRDA), Pakistan
\nGlobal Media Foundation, Ghana
\nGlobal Network of People Living with HIV (GNP+), Global
\nGlobal Tuberculosis Community Advisory Board (TB CAB), Global
\nGrupo de Ativistas em Tratamentos (GAT), Portugal
\nHawaii Health and Harm Reduction Center, United States
\nHealth and Development Alliance (HEAD), Cambodia
\nHealth GAP (Global Access Project), Global
\nHealth Justice Initiative, South Africa
\nHealth Poverty Action, United Kingdom
\nHep Free Hawaii, United States
\nHepatitis C Mentor and Support Group (HCMSG), United States
\nHIV Legal Network, Canada
\nInstitut de la soci\u00e9t\u00e9 civile pour le VIH et la sant\u00e9 en Afrique Ouest et Centre, Senegal
\nInteragency Coalition on AIDS and Development, Canada
\nInternational Treatment Preparedness Coalition (ITPC), South Africa
\nITPC-South Asia, South Asia
\nJointed Hands Welfare Organisation, Zimbabwe
\nJSH Consulting, Germany
\nKANCO, Kenya
\nKenya Treatment Access Movement (KETAM), Kenya
\nKhmer HIV\/AIDS NGO Alliance (KHANA), Cambodia
\nLeona Foundation, Kenya
\nLeprosy and TB Relief Initiative (LTR), Nigeria
\nLHL International Tuberculosis Foundation, Norway
\nMalawi Network of Religious Leaders Living with or Personally Affected by HIV and AIDS
\n(MANERELA+), Malawi
\nMambokaaje CBO, Kenya
\nMaryknoll Sisters, United States
\nM\u00e9decins Du Monde Mission in South Caucasus, Georgia
\nM\u00e9decins Sans Fronti\u00e8res – Access Campaign, Switzerland
\nMedical IMPACT, Mexico
\nMeera Foundation, India
\nMontefiore Medical Center, United States
\nNamibia Diverse Women’s Association (NDWA), Namibia
\nNational Coalition of People Living with HIV in India (NCPI Plus), India
\nNetwork of TB Champions, Kenya
\nNGO IRD, Ukraine
\nNGO RIEC “INTILISH”, Uzbekistan
\nNorthwest Coalition for Responsible Investment, United States
\nOrganisation for Health in Sustainable Development (OHISD), Cameroon
\nPamoja TB Group, Kenya
\nPartners In Health, Global
\nPhilippine Business for Social Progress, Philippines
\nPositive Malaysian Treatment Access & Advocacy Group (MTAAG+), Malaysia
\nPositive Women’s Network USA, United States
\nPublic Health Action, South Africa
\nRomanian Association Against AIDS (ARAS), Romania
\nSan Francisco AIDS Foundation, United States
\nSan Francisco Hepatitis C Task Force, United States
\nSection 27, South Africa
\nSikkim Drug Users’ Forum, India
\nSisters of Charity of Saint Elizabeth, United States
\nSisters of St. Francis of Philadelphia, United States
\nSocial Awareness Service Organisation, India
\nSocialist Party, India
\nSociety for Women against AIDS in Africa (SWAA SENEGAL), Senegal
\nSwaziland Migrant Mineworkers Association (SWAMMIWA), Eswatini
\nTB Proof, South Africa
\nThe Botswana Network on Ethics, Law & HIV\/AIDS (BONELA), Botswana
\nThe International Union Against TB and Lung Disease, France
\nThe Sentinel Project on Pediatric Drug Resistant Tuberculosis, United States
\nThird World Network, Malaysia
\nTINPSWALO ASSOCIATION – Vicentian Association to Fight AIDS & TB, Mozambique
\nTreatment Action Group (TAG), United States
\nTreatment Preparedness Coalition in Eastern Europe and Central Asia (ITPCru), Russian
\nFederation
\nTrinity Health, United States
\nTropical Logistics International Ltd., Kenya
\nUrban Survivors Union, United States
\nVolunteers for Development Nepal (VFDN), Nepal
\nWalter Sisulu University, South Africa
\nWote Youth Development Projects, Kenya
\nYale University School of Public Health, United States
\nYolse, Sant\u00e9 Publique et Innovation, Switzerland
\nZimbabwe Civil Liberties and Drug Network, Zimbabwe
\nZimbabwe Community Competence Trust, Zimbabwe<\/p>\n
1 WHO. Procurement considerations for COVID-19 diagnostics. [Online]. 2021 Jan 25 [cited 2021 Feb 10]. Available from:
\nhttps:\/\/www.who.int\/docs\/default-source\/coronaviruse\/procurement-considerations-for-covid-19-diagnostics.pdf?sfvrsn=70a480ce_16
\n2 360Dx. Danaher Q4 revenues up 39 percent. [Online]. 2021 Jan 28 [cited 2021 Feb 10]. Available from: https:\/\/www.360dx.com\/businessnews\/
\ndanaher-q4-revenues-39-percent#.YCbacNNKjUJ
\n3 MSF. Time for five: GeneXpert diagnostic tests. [Online]. 2019 Dec [cited 2021 Feb 10]. Available from: https:\/\/msfaccess.org\/time-for-5
\n4 US DHHS. BARDA\u2019s rapidly expanding COVID-19 medical countermeasure portfolio. [Online]. [cited 2021 Feb 10]. Available from:
\nhttps:\/\/www.medicalcountermeasures.gov\/app\/barda\/coronavirus\/COVID19.aspx
\n5 TB Online. Time to lower the price of Xpert cartridges to $5. [Online]. 2020 April [cited 2021 Feb 10]. Available from:
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