From Lab to Market: Paper‐Based CRISPR Diagnostics and Commercialization Pathways
Selen Dalgan, Qingshan Wei
Abstract
Abstract The global health landscape is continually challenged by infectious diseases that can swiftly escalate into pandemics, underscoring the need for rapid, accurate, and cost‐effective diagnostic technologies. CRISPR‐based diagnostics (CRISPR‐Dx) has emerged as a promising solution, offering high sensitivity, specificity, and adaptability for pathogen detection. Recent advances leverage paper‐based devices to integrate sample preparation, amplification, and CRISPR‐mediated detection into compact, user‐friendly formats. These systems exploit paper's inherent advantages—low cost, ease of fabrication, and minimal fluid‐handling requirements—to support molecular assays that generate clear visual readouts. Notable developments span from simple dipstick tests to fully integrated point‐of‐care (POC) platforms, each designed to address real‐world constraints such as limited resources and minimal operator training. While significant strides have been made in reagent stabilization, automation, and preamplification‐free protocols, several challenges remain. Ensuring robust performance in complex samples, reducing contamination risks, and achieving true POC readiness without specialized equipment are key hurdles. As CRISPR‐based paper diagnostics continue to mature, ongoing innovations in device engineering, reagent stabilization, and multiplexing will be essential for commercialization and broader clinical impact. This review discusses the current state of CRISPR‐based paper assays, highlights major technical breakthroughs, and explores strategies for realizing their full potential as commercially accessible POC diagnostics worldwide.