Periodic Reporting for period 1 - SCOPE (Leveraging CRISPR-Cas for fast and accurate point-of-care diagnostics)
Berichtszeitraum: 2024-03-01 bis 2025-02-28
By bridging the gap between centralized lab diagnostics and real-time point-of-care testing, the SCOPE project and its scopeDx® technology 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 like sepsis, respiratory infections, 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 use, requiring minimal equipment, reducing reliance on centralized laboratories, and making molecular diagnostics more accessible, even in resource-limited settings.
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 a demonstrator case in transplant diagnostics, 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 agri-food safety.
4. Go-to-Market strategy – Build a sustainable business model, map out the needed regulatory approvals and establish strategic partnerships to accelerate commercialization.
5. Investment and market readiness – Validate scopeDx®’s economic and clinical value to attract funding for large-scale clinical trials and global 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 like sepsis, respiratory infections, 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 use, requiring minimal equipment, reducing reliance on centralized laboratories, and making molecular diagnostics more accessible, even in resource-limited settings.
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 a demonstrator case in transplant diagnostics, 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 agri-food safety.
4. Go-to-Market strategy – Build a sustainable business model, map out the needed regulatory approvals and establish strategic partnerships to accelerate commercialization.
5. Investment and market readiness – Validate scopeDx®’s economic and clinical value to attract funding for large-scale clinical trials and global market entry.
The work carried out has focused on technical optimization, assay validation, industrialization.
The main achievements are:
System optimization: We are in the process of developing and tested a rapid mouth swab-based extraction method that ensures DNA/RNA accessibility within 15 minutes, eliminating the need for complex lab equipment. Besides, we have evaluated five off-the-shelf devices and selected the one which met most criteria, including ISO 13485 compliance.
Preclinical validation: We have designed and are validated five HLA scopeDx® assays capable of detecting, amongst other mutations, single nucleotide mutations important in transplant diagnostics. These assays are currently undergoing validation on synthetic target material and will soon be performed on human genome samples. These preliminary validations on synthetic targets demonstrate high specificity, meeting key technical benchmarks for clinical use.
Industrialization and assay design automation: We have developed a web-based crRNA design tool to automate and streamline assay development, reducing human error and enhancing specificity. We are identifying production bottlenecks to optimize for but currently have a protein production capacity of 650,000 assays per year. Furthermore, we have successfully lyophilized assays for room-temperature stability, reducing reliance on cold-chain logistics.
The main achievements are:
System optimization: We are in the process of developing and tested a rapid mouth swab-based extraction method that ensures DNA/RNA accessibility within 15 minutes, eliminating the need for complex lab equipment. Besides, we have evaluated five off-the-shelf devices and selected the one which met most criteria, including ISO 13485 compliance.
Preclinical validation: We have designed and are validated five HLA scopeDx® assays capable of detecting, amongst other mutations, single nucleotide mutations important in transplant diagnostics. These assays are currently undergoing validation on synthetic target material and will soon be performed on human genome samples. These preliminary validations on synthetic targets demonstrate high specificity, meeting key technical benchmarks for clinical use.
Industrialization and assay design automation: We have developed a web-based crRNA design tool to automate and streamline assay development, reducing human error and enhancing specificity. We are identifying production bottlenecks to optimize for but currently have a protein production capacity of 650,000 assays per year. Furthermore, we have successfully lyophilized assays for room-temperature stability, reducing reliance on cold-chain logistics.
The expected impacts achievable with our scopeDx® platform are:
Faster and more accurate diagnoses – Reducing time-to-results from days to minutes improves patient survival rates, treatment outcomes, and resource efficiency in hospitals.
Transforming diagnostics in high-accuracy and PoC applications – Providing portable, lab-free diagnostics for diseases like sepsis, respiratory infections, emerging pathogens and high accuracy gene-typing applications such as transplant diagnostics.
Scalable and versatile platform – The adaptable scopeDx® technology can be extended to other high-impact fields like antimicrobial resistance monitoring, agricultural applications, food safety, and veterinary diagnostics.
Economic and societal benefits – Reducing healthcare costs by minimizing hospital stays, unnecessary treatments, and logistical burdens associated with traditional lab testing.
Faster and more accurate diagnoses – Reducing time-to-results from days to minutes improves patient survival rates, treatment outcomes, and resource efficiency in hospitals.
Transforming diagnostics in high-accuracy and PoC applications – Providing portable, lab-free diagnostics for diseases like sepsis, respiratory infections, emerging pathogens and high accuracy gene-typing applications such as transplant diagnostics.
Scalable and versatile platform – The adaptable scopeDx® technology can be extended to other high-impact fields like antimicrobial resistance monitoring, agricultural applications, food safety, and veterinary diagnostics.
Economic and societal benefits – Reducing healthcare costs by minimizing hospital stays, unnecessary treatments, and logistical burdens associated with traditional lab testing.