A sample is inserted into the GeneXpert machine in MSF's lab in Kerema General Hospital, Kerema. The machine has revolutionised TB diagnosis, detecting the TB bacterium and any drug resistance within a matter of hours.
Statement |

Principles for Access to Multi-disease Molecular Diagnostics

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Three years into the COVID pandemic and in the month (August 2022) marking the expiration of the 10-year Cepheid Xpert MTB/RIF buy-down, we are at a pivotal moment to take stock of lessons learned, ongoing and new challenges, and the enduring structural barriers that continue to prevent equitable access to molecular diagnostics for TB, HIV, viral hepatitis, HPV, other STIs, and COVID.

Treatment Action Group (TAG) and Médecins Sans Frontières (MSF) Access Campaign present here 10 Principles for Access to Multi-disease Molecular Diagnostics. These 10 Access Principles are intended to help country governments, donors, and global health actors work together to navigate the complex process of improving global, regional, and national systems for the procurement and implementation of essential molecular diagnostic tests. The Access Principles articulate approaches to promote competition, increase efficiency, reduce costs, improve the terms and provision of service and maintenance, and put in place measures to ensure that pricing of molecular diagnostics is transparent, fair, equitable, and evidence based. 

These Access Principles were developed based on discussions held among country program representatives, donors, members of civil society, and global health actors at the Roundtable on Access to Multi-disease Molecular Diagnostics, hosted by TAG and MSF on June 2, 2022. A report of the roundtable meeting is also shared here.

The Cepheid Xpert MTB/RIF buy-down accelerated the initial rollout of molecular TB testing in low- and middle-income countries, but it also inadvertently created a decade-long monopoly with high prices, lack of transparency in pricing, and inadequate service and maintenance. To make the next 10 years of diagnostics development and access more effective and equitable, we expect country governments, donors, and global health actors to apply these Access Principles to help re-shape the market and establish the conditions necessary for it to deliver equitable access to testing for infectious diseases. 

Principles for Access to Multi-disease Molecular Diagnostics

Meeting Report Roundtable on Access to Multi-disease Molecular Diagnostics