Diagnostic testing remains the backbone of the coronavirus disease 2019 (COVID-19) response, supporting containment efforts to mitigate the outbreak. The severity of this crisis and increasing capacity issues associated with polymerase chain reaction (PCR)-based testing, accelerated the development of diagnostic solutions to meet demands for mass testing. The National Institute for Health Research (NIHR) Innovation Observatory is the national horizon scanning organization in England. Since March, the Innovation Observatory has applied advanced horizon scanning methodologies and tools to compile a diagnostic landscape, based upon data captured for molecular (MDx) and immunological (IDx) based diagnostics (commercialized/in development), for the diagnosis of SARS-CoV-2. In total we identified and tracked 1608 diagnostics, produced by 1045 developers across 54 countries. Our dataset shows the speed and scale in which diagnostics were produced and provides insights into key periods of development and shifts in trends between MDx and IDx solutions as the pandemic progressed. Stakeholders worldwide required timely and detailed intelligence to respond to major challenges, including testing capacity and regulatory issues. Our intelligence assisted UK stakeholders with assessing priorities and mitigation options throughout the pandemic. Here we present the global evolution of diagnostic innovations devised to meet changing needs, their regulation and trends across geographical regions, providing invaluable insights into the complexity of the COVID-19 phenomena.

Over 500,000 people in England have a recorded diagnosis of dementia, of whom at least 40% have Alzheimer’s disease (AD) in isolation or in combination with other pathologies. Timely diagnosis ensures that people get the help and support they need. Mild cognitive impairment (MCI) is a term for subtle changes in memory, language and behaviour that do not impact on a person’s ability to function. People with MCI may develop AD or other dementias. This horizon scan, alongside an ultra-rapid evidence synthesis review, aimed to identify digital tests and devices which support the identification of MCI associated with early-stage AD. We searched clinical trial registries, news websites, patent databases, funding and regulatory agencies, and company websites, as well as three recently published systematic reviews. Eligible technologies were any digital tools to detect MCI or cognitive decline in adults without a current diagnosis of AD. 79 technologies were identified, classified as digitised versions of standard cognitive tests, newly developed digital cognitive tests, and digital devices that incorporate detection of MCI/cognitive decline. This work outlines digital technologies, at various development stages, that might complement emerging treatments in the care pathway by facilitating identification of AD at the earlier stages of clinical presentation.