CPSA 4 Corners Initiative

 

Mission

Through collaborative scientific discourse, develop integrated processes to guide development of cutting-edge technology and drive its translation directly into the clinic or home for the purpose of improving personal health and overall wellbeing.

Key themes: simplified, robust, intuitive, automated, fast, generalizable, streamlined data management

Technology

Miniaturized, simplified, intuitive (minimal training needed), cost effective, robust, consistent, generalizable for methods, adaptable, minimal/no ancillary equipment required, single use or disposable components, resistant to environment, able to communicate to user/physician (receive, store, send, interpret data, present to end user), parallel processing/high throughput, fast

Methodology

High level of analytical sensitivity and specificity (accuracy), reproducible, robust, streamlined, generalizable for analytes and matrices, implementable under ambient conditions, self-contained, parallel processing, fast, standardized/harmonized methods, minimal use of disposables and solvents (perhaps this is only for home-based systems), Should we be targeting multi analyte? Drugs as well as biomarkers? For biomarkers, a metabolomics-type ability would be great.

Workflow/Process

Maximized process efficiency, seamless, intuitive, entirely automated and streamlined for: data management, quality assurance measures, data interpretation, data presented in a digestible format Develop robust infrastructure and supply lines to reliably support technology and methods: equipment/reagents/personnel/procedures/training/service and support (for home use especially, would we want/need expert checks of data – e.g., glucose levels don’t need a physician check for the patient to know what to do, but a spike in liver enzymes in the blood might)

Regulation

To support regulatory compliance - processes that are auditable, compliance metrics automatically collected and stored, FDA approved[?] To assist regulatory guidance development – regulatory work groups and collaborations, publications

Informatics

Automated data storage, data interpretation models, secure/HIPPA compliant, harmonized or standardized system – compatible with different EMRs, capable of sorting and reporting data for accountable care. Ability to provide trend analyses of current measurement against previous.