Periodic Reporting for period 2 - SCOPE (Leveraging CRISPR-Cas for fast and accurate point-of-care diagnostics)
Período documentado: 2025-03-01 hasta 2026-02-28
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.
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.
The work carried out has focused on technical optimization, assay validation, and industrialization.
The main achievements are:
System optimization: We have developed and tested a rapid mouth swab-based extraction method that ensures DNA/RNA accessibility within 15 minutes, eliminating the need for complex lab equipment. In addition, we evaluated five off-the-shelf devices and selected the one that met most criteria, including compatibility with ISO 13485 requirements.
Preclinical validation: We have designed and validated five HLA scopeDx® assays and a reference assay capable of detecting, amongst other mutations, single nucleotide variants important in transplant diagnostics, These assays have been validated on synthetic target material and on human genomic samples. These validations demonstrate high specificity, meeting key technical benchmarks for clinical use. Next to this the demonstrator cases were expanded with multiple infectious disease collaborations.
Industrialization and assay design automation: We have developed a web-based crRNA design tool to streamline assay development, reducing human error and enhancing specificity. In parallel, we evaluated production processes and identified potential bottlenecks. Based on current yields, the protein production capacity is estimated at approximately 650,000 assays per year. Furthermore, we have successfully lyophilized assays for room-temperature stability, reducing reliance on cold-chain logistics.
Quality management and regulated production readiness: An ISO 13485–compliant quality management system was implemented to support regulated reagent production and ensure traceability and quality control throughout the assay development and manufacturing workflow. This milestone enables the production of diagnostic reagents under a regulated framework and supports integration of the scopeDx® technology into partner diagnostic development programs.
The main achievements are:
System optimization: We have developed and tested a rapid mouth swab-based extraction method that ensures DNA/RNA accessibility within 15 minutes, eliminating the need for complex lab equipment. In addition, we evaluated five off-the-shelf devices and selected the one that met most criteria, including compatibility with ISO 13485 requirements.
Preclinical validation: We have designed and validated five HLA scopeDx® assays and a reference assay capable of detecting, amongst other mutations, single nucleotide variants important in transplant diagnostics, These assays have been validated on synthetic target material and on human genomic samples. These validations demonstrate high specificity, meeting key technical benchmarks for clinical use. Next to this the demonstrator cases were expanded with multiple infectious disease collaborations.
Industrialization and assay design automation: We have developed a web-based crRNA design tool to streamline assay development, reducing human error and enhancing specificity. In parallel, we evaluated production processes and identified potential bottlenecks. Based on current yields, the protein production capacity is estimated at approximately 650,000 assays per year. Furthermore, we have successfully lyophilized assays for room-temperature stability, reducing reliance on cold-chain logistics.
Quality management and regulated production readiness: An ISO 13485–compliant quality management system was implemented to support regulated reagent production and ensure traceability and quality control throughout the assay development and manufacturing workflow. This milestone enables the production of diagnostic reagents under a regulated framework and supports integration of the scopeDx® technology into partner diagnostic development programs.
The results achieved with the scopeDx® platform contribute to the following impacts:
Faster and more accurate diagnoses – The development and validation of scopeDx® assays demonstrates the feasibility of reducing molecular diagnostic turnaround times from hours or days to less than 30 minutes, enabling faster clinical decision-making and more efficient use of healthcare resources.
Transforming diagnostics in high-specificity and PoC applications – The successful development of scopeDx® assays for HLA typing and Infectious Diseases demonstrates the ability of the platform to detect single nucleotide variants with high specificity, supporting applications such as transplant diagnostics and infectious disease detection where accurate genetic identification is critical.
Scalable and versatile platform – The development of a crRNA assay design tools, portable readout compatibility, and scalable production workflows demonstrates that the scopeDx® platform can be adapted for a wide range of molecular diagnostic applications. The technology architecture also allows extension to additional sectors such as antimicrobial resistance monitoring, agriculture, food safety, and veterinary diagnostics.
Economic and societal benefits – By enabling rapid and decentralized molecular diagnostics, the scopeDx® platform has the potential to reduce healthcare costs associated with centralized laboratory testing, unnecessary treatments, and prolonged hospital stays, while strengthening preparedness for infectious disease outbreaks.
Further uptake and commercialization – The establishment of scalable production processes, implementation of an ISO 13485–compliant quality management system, and development of strategic partnerships provide the foundation for further clinical validation, regulatory approval, and commercialization of scopeDx®-based diagnostic solutions.
Faster and more accurate diagnoses – The development and validation of scopeDx® assays demonstrates the feasibility of reducing molecular diagnostic turnaround times from hours or days to less than 30 minutes, enabling faster clinical decision-making and more efficient use of healthcare resources.
Transforming diagnostics in high-specificity and PoC applications – The successful development of scopeDx® assays for HLA typing and Infectious Diseases demonstrates the ability of the platform to detect single nucleotide variants with high specificity, supporting applications such as transplant diagnostics and infectious disease detection where accurate genetic identification is critical.
Scalable and versatile platform – The development of a crRNA assay design tools, portable readout compatibility, and scalable production workflows demonstrates that the scopeDx® platform can be adapted for a wide range of molecular diagnostic applications. The technology architecture also allows extension to additional sectors such as antimicrobial resistance monitoring, agriculture, food safety, and veterinary diagnostics.
Economic and societal benefits – By enabling rapid and decentralized molecular diagnostics, the scopeDx® platform has the potential to reduce healthcare costs associated with centralized laboratory testing, unnecessary treatments, and prolonged hospital stays, while strengthening preparedness for infectious disease outbreaks.
Further uptake and commercialization – The establishment of scalable production processes, implementation of an ISO 13485–compliant quality management system, and development of strategic partnerships provide the foundation for further clinical validation, regulatory approval, and commercialization of scopeDx®-based diagnostic solutions.