By bridging the gap between centralized lab diagnostics and real-time point-of-care testing, the SCOPE project and its scopeDx® technology platform is set to revolutionize molecular diagnostics, making accurate and rapid (genetic) testing more accessible, scalable, and impactful for healthcare worldwide.
In fact, the SCOPE project addresses a critical gap in healthcare diagnostics by developing a rapid, cost-effective, and highly accurate point-of-care (PoC) diagnostic platform leveraging CRISPR-Cas technology. Current diagnostic tools often make a tradeoff between speed, accuracy, affordability, and portability. While rapid tests like immunoassays offer speed and ease of use, they lack accuracy. Conversely, gold-standard molecular diagnostics like PCR are highly accurate but slow, expensive, and require specialized lab facilities. This creates a significant bottleneck in medical decision-making, particularly for time-sensitive conditions such as infectious disease diagnostics and organ transplant compatibility testing, where every minute matters.
The scopeDx® technology merges the high specificity of CRISPR-Cas detection with the speed and simplicity of isothermal amplification (RT-LAMP), enabling (SNP-level) accurate genetic analysis in under 30 minutes. It is designed for bedside or decentralized use, requiring minimal equipment, reducing reliance on centralized laboratories, and making molecular diagnostics more accessible, even in resource-limited settings. The platform is compatible with widely available portable fluorescence readers and can operate with simplified sample preparation workflows.
The main project objectives are:
1. Technology development and validation – Optimize and validate a user-friendly, single-step CRISPR-based diagnostic assay for critical healthcare applications.
2. Clinical demonstration – Prove the feasibility of scopeDx® in real-world settings, with demonstrator cases in transplant diagnostics and infectious diseases, where accurate and rapid detection of genetic markers is essential.
3. Scalability and industrialization – Enhance the manufacturing process, reduce costs, and develop a standardized, easily adaptable diagnostic platform for multiple applications, including human healthcare and exploratory agri-food diagnostics.
4. Go-to-Market strategy – Build a sustainable business model, map out the required regulatory approvals, and establish strategic partnerships, including integration of the technology through the scopeDx®-Inside model.
5. Investment and market readiness – Validate scopeDx®’s economic and clinical value to attract funding for market entry.
