Periodic Reporting for period 1 - Molecular Culture (World’s first diagnostic test that can detect all bacterial species in a single assay)
Período documentado: 2023-09-01 hasta 2024-08-31
Worldwide, one in five human deaths are caused by bacterial infections. Diagnostics for these infections largely rely on traditional bacterial culture methods, which take several days to yield results. This delay contributes to prolonged hospital stays, worsening patient conditions, and increased healthcare costs. Additionally, the slow diagnostic process often leads to the empirical use of antibiotics, which exacerbates the issue of antimicrobial resistance (AMR).
Our Molecular Culture project addresses these challenges with a novel PCR-based test technology that delivers accurate results within 5 hours, identifying hundreds of bacterial species. This rapid diagnostic capability enables targeted antibiotic administration, leading to improved patient outcomes, shorter hospital stays, and reduced healthcare costs.
The primary objective of this project is to optimize the Molecular Culture testing platform and conduct clinical validations to prepare it for FDA and IVDR approval, ultimately paving the way for market entry. This will involve refining the technology, ensuring reliability, and building the necessary evidence to support regulatory approvals and market adoption.
Our Molecular Culture project addresses these challenges with a novel PCR-based test technology that delivers accurate results within 5 hours, identifying hundreds of bacterial species. This rapid diagnostic capability enables targeted antibiotic administration, leading to improved patient outcomes, shorter hospital stays, and reduced healthcare costs.
The primary objective of this project is to optimize the Molecular Culture testing platform and conduct clinical validations to prepare it for FDA and IVDR approval, ultimately paving the way for market entry. This will involve refining the technology, ensuring reliability, and building the necessary evidence to support regulatory approvals and market adoption.
During the first year of the molecular culture project, we have made significant strides in both technological development and clinical validation. Our team successfully developed a cloud-based software platform that serves as the foundation for our molecular diagnostic solution. This platform enhances data integration and analysis, providing a robust and scalable environment for processing complex molecular data.
We optimized our test technology to improve its accuracy and reliability, ensuring it meets the rigorous demands of clinical settings. This optimized technology was validated through clinical trials across seven different hospital workflows. The trials demonstrated the accuracy, versatility and effectiveness of our solution in diverse clinical environments, confirming its potential for widespread adoption.
To facilitate real-world application and gather practical insights, we initiated pilot programs in partner hospitals. These pilots are crucial for testing our technology in everyday clinical scenarios, allowing us to refine workflows and address any operational challenges. Feedback from these pilots has been instrumental in fine-tuning our solution to better meet the needs of healthcare professionals.
In preparation for market entry, we produced all necessary documentation for In Vitro Diagnostic Regulation (IVDR) approval. This comprehensive documentation underscores our commitment to compliance with regulatory standards and positions us favorably for successful certification within the European market. A significant achievement during this period was receiving the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation acknowledges the innovative nature of our technology and its potential to offer more effective diagnosis or treatment of life-threatening diseases. It provides us with an expedited review process, facilitating a faster route to market in the United States. Additionally, it offers support with reimbursement pathways, which is essential for commercial viability and ensuring patient access to our technology.
Overall, the activities performed and achievements realized during this reporting period have substantially advanced the project. We have established a strong technological foundation, validated our solution in clinical settings, navigated regulatory pathways, and positioned ourselves strategically for market entry and adoption.
We optimized our test technology to improve its accuracy and reliability, ensuring it meets the rigorous demands of clinical settings. This optimized technology was validated through clinical trials across seven different hospital workflows. The trials demonstrated the accuracy, versatility and effectiveness of our solution in diverse clinical environments, confirming its potential for widespread adoption.
To facilitate real-world application and gather practical insights, we initiated pilot programs in partner hospitals. These pilots are crucial for testing our technology in everyday clinical scenarios, allowing us to refine workflows and address any operational challenges. Feedback from these pilots has been instrumental in fine-tuning our solution to better meet the needs of healthcare professionals.
In preparation for market entry, we produced all necessary documentation for In Vitro Diagnostic Regulation (IVDR) approval. This comprehensive documentation underscores our commitment to compliance with regulatory standards and positions us favorably for successful certification within the European market. A significant achievement during this period was receiving the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation acknowledges the innovative nature of our technology and its potential to offer more effective diagnosis or treatment of life-threatening diseases. It provides us with an expedited review process, facilitating a faster route to market in the United States. Additionally, it offers support with reimbursement pathways, which is essential for commercial viability and ensuring patient access to our technology.
Overall, the activities performed and achievements realized during this reporting period have substantially advanced the project. We have established a strong technological foundation, validated our solution in clinical settings, navigated regulatory pathways, and positioned ourselves strategically for market entry and adoption.
The Molecular Culture project has achieved groundbreaking advancements that significantly surpass the current standards in bacterial infection diagnostics:
Key Achievements:
• Rapid PCR-Based Test Technology: We have developed a novel PCR-based diagnostic technology that delivers accurate results within five hours, identifying hundreds of bacterial species simultaneously. This is a substantial improvement over the multi-day wait times associated with traditional culture methods.
• Cloud-Based Software Platform: Our team created an integrated cloud-based platform that enhances data processing and analysis. This platform supports real-time diagnostics and facilitates seamless collaboration across different clinical settings, overcoming the limitations of isolated systems.
• Improved accuracy over the state of the art: In the clinical validations performed to date our technology was demonstrated not only to be much faster than standard culture, but also showed significantly increased accuracy: in all clinical workflows, a significant proportion (>20%) of samples that had been found negative by the current state-of-the-art, were shown to be positive with our technology. These additional positives represented highly relevant pathogens, detection of which would often have impacted therapeutic decisions.
• Regulatory Milestones: We have prepared comprehensive documentation for In Vitro Diagnostic Regulation (IVDR) approval and received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation accelerates the review process and supports reimbursement pathways, crucial for market entry and adoption.
Key Needs for Uptake and Success:
1) Regulatory Approvals: Finalize FDA clearance and IVDR approval with continued regulatory engagement.
2) Expand Partnerships: Build strategic ties with healthcare providers, showing clinical and economic benefits through pilot programs.
3) Reimbursement Pathways: Develop reimbursement strategies to ensure financial accessibility for healthcare providers and patients.
4) Marketing & Business Development: Continue efforts to boost brand and product awareness among healthcare professionals.
Key Achievements:
• Rapid PCR-Based Test Technology: We have developed a novel PCR-based diagnostic technology that delivers accurate results within five hours, identifying hundreds of bacterial species simultaneously. This is a substantial improvement over the multi-day wait times associated with traditional culture methods.
• Cloud-Based Software Platform: Our team created an integrated cloud-based platform that enhances data processing and analysis. This platform supports real-time diagnostics and facilitates seamless collaboration across different clinical settings, overcoming the limitations of isolated systems.
• Improved accuracy over the state of the art: In the clinical validations performed to date our technology was demonstrated not only to be much faster than standard culture, but also showed significantly increased accuracy: in all clinical workflows, a significant proportion (>20%) of samples that had been found negative by the current state-of-the-art, were shown to be positive with our technology. These additional positives represented highly relevant pathogens, detection of which would often have impacted therapeutic decisions.
• Regulatory Milestones: We have prepared comprehensive documentation for In Vitro Diagnostic Regulation (IVDR) approval and received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation accelerates the review process and supports reimbursement pathways, crucial for market entry and adoption.
Key Needs for Uptake and Success:
1) Regulatory Approvals: Finalize FDA clearance and IVDR approval with continued regulatory engagement.
2) Expand Partnerships: Build strategic ties with healthcare providers, showing clinical and economic benefits through pilot programs.
3) Reimbursement Pathways: Develop reimbursement strategies to ensure financial accessibility for healthcare providers and patients.
4) Marketing & Business Development: Continue efforts to boost brand and product awareness among healthcare professionals.