Technology Core

Abstract:

The global market for point‐of‐care (POC) tests is projected to grow 12% annually, exceeding US$90B by 2030. Drivers of market growth include emerging disease threats, increasing demand for self‐testing, successful market shaping

interventions, increasing demand for essential diagnostics in low‐ and middle‐income countries (LMICs), and a trend for health‐care decentralization. More than a billion COVID‐19 tests are now performed annually at the POC, and the pandemic testing response demonstrated that: a new generation of high performance, affordable molecular tests can be

manufactured, distributed, and rapidly adapted for new targets; a broad segment of users can accurately perform home testing; and test results can enable rapid treatment when needed. The POCTRN network contributed significantly to these

successes. Despite the success of RADx and the rapid scale of POC testing for COVID, a number of significant barriers still

remain to achieve the potential of POC testing, especially for the early detection of cancer. The mission of The Technology

Core of The Center for Innovation and Translation of Point‐of‐Care Technologies for Equitable Cancer Care (CITEC) is to

join POCTRN in supporting and accelerating the development and translation of high priority POC technologies specifically

designed for cancer screening and early detection for under‐served populations. The first aim of the Technology Core (TC) is to identify and support new meritorious projects to develop POC technologies for cancer screening or early cancer

detection from prototype through early clinical testing. In collaboration with the Dissemination Core, the TC will conduct assessments to identify high priority unmet clinical needs for cancer screening and early detection, and, subsequently, publish consensus POC Technology Needs Statements. CITEC will issue targeted solicitations offering funding to address

these needs. The TC will support technology projects specifically designed for underserved communities, including those

designed to address challenges and barriers associated with cancer health disparities and low‐resource settings (e.g., rural

settings, settings with limited infrastructure). The second aim of the TC is to assist supported POC technology developers

to refine their clinical needs statement, including target test specifications, and refine and assess technical performance,

usability, and manufacturability of their technology, with the objective of accelerating the path to translation and clinical adoption. The TC will create a CITEC Core Technology Laboratory with unique and comprehensive technical resources to support the design, fabrication and rapid optimization of POC imaging technologies, POC molecular sensors, and machine

learning based image analysis strategies appropriate for mobile platforms. The third aim of the TC is to help translate

promising prototypes to clinical validation and commercialization. The TC will work closely with the Clinical Core to identify

technologies ready for clinical evaluation and to support the transition to evaluation in relevant clinical settings. The TC will work with POC test developers to accelerate efforts to develop commercial prototypes and to develop successful

commercialization strategies, leveraging resources in the Texas Medical Center and in Brazil. Through these aims, the TC

will work with other CITEC cores to build and support a robust pipeline of POC technologies for equitable cancer screening and early detection.