Advocates request Cepheid increase access to GeneXpert SARS-CoV-2 tests in LMICs

On 25 February 2021, advocates concerned about the lack of access to Cepheid’s GeneXpert SARS-CoV-2 tests in low- and middle-income countries (LMICs), sent an open letter to the company requesting 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 to $5.

“… Cepheid’s GeneXpert SARS-CoV-2 test is critical for LMICs given the existing placement of Cepheid’s GeneXpert instruments in these countries. We are disappointed, therefore, that Cepheid has continued to undersupply LMICs through the Diagnostics Consortium…  It is shameful that less than 15% of Cepheid’s 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.”

“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. Based on the fact that Cepheid’s global annual sales volume in 2021 will likely exceed 36 million COVID-19 tests, in addition to sales volumes for other diseases, a price reduction is long overdue…”

In the letter, the signatories reiterated as well previous appeals from civil society and affected communities to Cepheid to decrease the price of its other GeneXpert tests, including for TB, HIV, HBV, and HCV to $5, inclusive of service and maintenance.

“This price better 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.”

The signatories requested a response by 11 March 2021.

To read the full letter, click here.

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On March 13th, Cepheid responded but did not provide any substantive information or address the core requests from civil society, referring to the prices offered to LMICs for Xpert tests as “compassionate” and implying that the volumes of Xpert SARS-CoV-2 tests distributed to LMICs were adequate despite continued unmet demand and need.

For the full response, click here.

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Given Cepheid's dismissive response, on April 1, 2021, 142 civil society organizations instead sent an open letter to the donors, countries, and health actors copied on the 25 February open letter to Cepheid. In the 1 April letter, civil society appealed to these leading health actors to improve access to GeneXpert and other diagnostics for COVID-19, TB, HIV, HBV, HCV, and other diseases by (1) applying collective leverage in negotiations with Cepheid for lower prices and sufficient volumes; (2) establishing cost-of-goods-sold (COGS)-plus and volume-based pricing for diagnostics as a global norm; and (3) increasing investments in alternative rapid molecular tests to promote competition and improve access.

To read the full letter, click here.

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On May 21, the leadership of the Access to COVID-19 Tools Accelerator (ACT-A) Diagnostics Pillar (FIND, WHO, and the Global Fund) sent a letter in response to the April 1st open letter from civil society and affected communities.

In the response, FIND, WHO, and the Global Fund committed the ACT-A Diagnostics Pillar to:

1. “Continue negotiations with Cepheid to increase the allocation and secure more favorable terms for GeneXpert SARS-CoV-2 tests for LMICs.
2. Across diagnostic tests and going forward for any new tests, develop a standardized COGS methodology to feed into discussions on fair pricing.
3. In partnership with countries, specialized agencies, and civil society organizations, support, accelerate and coordinate rollout of innovations in the rapid molecular testing pipeline, as well as other testing modalities, including prequalification / emergency use listing, country readiness and national scale-up. In addition, grow and strengthen FIND’s existing academic clinical evaluation lab network.
4. Continue engagements with countries and other relevant actors on a diversification strategy for COVID-19 testing at national and community levels, leveraging the full portfolio of COVID-19 diagnostic tools.”

The leadership further noted: “Across all these interventions, we welcome the participation of civil society organizations – we value your partnership and collaboration in our shared goals for equitable access to diagnostics and look forward to continuing our work together."

To read the full letter, click here.

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On 15 June 2021, the Time for $5 Coalition sent an open letter acknowledging the commitments of the ACT-Accelerator Diagnostics Pillar and calling on the members of the ACT-A and Integrated Diagnostics Consortium (IDC) to:

• de-silo ongoing discussions in order to collectively negotiate with Cepheid for $5 Xpert tests, inclusive of service and maintenance, across diseases;
• increase competition by scaling up Truenat and other multi-disease testing platforms; and
• develop a coordinated strategy to advance and operationalize these objectives.

To read the full letter, click here.