The diagnostic journey

From R&D to implementation, the diagnostic value chain can be thought of as a journey of interconnected steps, or a "virtuous cycle".

Despite tremendous progress, millions of people still lack the right diagnostics technologies and tools to combat health challenges. R&D addresses these challenges by translating an idea or concept into diagnostic tools. Tests can be developed to detect a single disease, but increasingly manufacturers are exploring multi-pathogen testing platforms that can be used to diagnose multiple diseases.

At FIND, our Technology & Development department proactively scouts for promising new technologies, and partners with industry and manufacturers on product development to ensure that tools in the pipeline are optimized for use in low-resource settings. We work on digital health solutions as well as technologies for disease surveillance, including sequencing and genomics. We also provide tools to support development of tests, including through our own FIND Specimen Bank and the DxConnect Virtual Biobank Directory.

Without regulatory approval, products developed from the R&D phase should not be approved for use. Regulatory authorities are entrusted by governments to validate that available products are legally authorized, safe, and perform as claimed when used according to directions.

At FIND, our Medical Affairs department has a global network of clinics and academic institute partners that we work with to generate independent evidence on the performance of new tools, in the settings in which they will be ultimately used. Manufacturers can include these data as part of their submission package when seeking approval from WHO or local country regulatory authorities.

Once regulatory approval is received and countries have policies in place to deploy diagnostic technologies and tools, products must be made available for purchase. Products must be manufactured or produced, and the volume or the amount of supply produced should be linked to global and country requirements.

At FIND, our Technology & Development department works with industry and in-country manufacturers to identify opportunities and support technology transfer for local manufacturing.

As tests are made available by manufacturers, strong procurement systems and supply chains ensure that the right tools are deployed to the right places at the right time. Strong procurement and supply management systems preserve the quality and availability of products from manufacturers to countries in need.

At FIND, our Access department works on market innovations to make market information more transparent and diagnostic prices more affordable. In partnership with industry, global health procurement agencies and private sector buyers, we support the roll-out of new tests, as well as providing tools to fill gaps where no global procurement mechanism currently exists, for example connecting buyers and sellers through the DxConnect Marketplace.

As diagnostics tools become available, advocacy and awareness efforts are needed to ensure consumption. Diagnostics advocacy enables decision makers to develop public health strategies and empowers individuals in seeking care.

At FIND we work with partners on targeted advocacy efforts from global and ministerial to community levels, to raise the profile of testing and increase diagnostic literacy. We support the development of mutually agreed accountability frameworks, including country action plans, to strengthen commitment to testing and monitor the implementation of diagnostic strategies, and ensure continued assessment of our work.

Once quality-assured tools are available to countries, this phase ensures they are introduced and integrated into health systems. Scaling up and sustaining the use of diagnostics requires decentralized testing, healthcare worker training, laboratory systems strengthening and integration of testing for different diseases where relevant (such as COVID-19 testing being integrated into country TB programmes).

At FIND, our Access department works directly with governments and other stakeholders to support the implementation, scale up and sustainability of new tests. We also develop and delivers both online and onsite training on multiple different aspects of diagnostic testing.