Periodic Reporting for period 2 - MICK (Translational Microbiome Platform)
Période du rapport: 2023-09-01 au 2025-02-28
The human microbiome, comprising trillions of microorganisms in our bodies, plays a key role in maintaining health and preventing diseases. Dysbiosis, or microbial imbalance, significantly increases chronic disease risks. Early microbiome intervention is vital for preventive healthcare as these conditions rise.
Beyond chronic diseases, the microbiome impacts infectious disease management. It serves as a biomarker for infection risk in those with chronic conditions. Microbiome analysis enhances pathogen identification, outbreak characterization, and treatment selection, potentially transforming infectious disease diagnostics.
Despite its immense potential, microbiome analysis remains largely inaccessible to most healthcare practitioners. Current solutions are complex, expensive, and designed primarily for experts, requiring specialized bioinformatics knowledge and IT infrastructure. This hinders routine clinical adoption, limiting the ability of doctors to use microbiome-based diagnostics in patient care.
Our project addresses this challenge through MICK©, a pioneering microbiome analysis platform designed to make scientifically backed microbiome testing widely accessible to healthcare professionals.
MICK is the first platform to offer real-time, automated microbiome analysis, providing evidence-based recommendations for personalized patient care. Unlike existing solutions, MICK:
- Accurately profiles the microbiome, extracting critical insights from sequencing data
- Translates results into patient-specific treatment suggestions, considering phenotypic and genetic factors
- Automates analysis workflows, eliminating the need for coding skills or advanced bioinformatics expertise
- Operates seamlessly across different sequencing technologies, ensuring flexibility and broad adoption
- Supports multiple microbiome types, going beyond traditional gut microbiome testing
- Allows accurate identification of Class B pathogens (IVDR module)
By leveraging cutting-edge microbiome science, MICK contributes to tackling some of the most pressing healthcare challenges in Europe. MICK was developed to:
1.Make microbiome analysis accessible to healthcare professionals, thereby expanding the use of targeted preventive medicine.
2.Bridge the gap between microbiome research and clinical practice, bringing scientific advances from the lab to patient care.
3.Reduce health disparities by enabling wider adoption of microbiome-based diagnostics, improving global health and longevity.
MICK is designed to be used by healthcare professionals, particularly doctors, geneticists, and clinical researchers . By simplifying and democratizing microbiome science, MICK empowers physicians to integrate microbiome-based diagnostics into routine medical practice, enhancing clinical decision-making, particularly for complex conditions.
Beyond chronic diseases, the microbiome impacts infectious disease management. It serves as a biomarker for infection risk in those with chronic conditions. Microbiome analysis enhances pathogen identification, outbreak characterization, and treatment selection, potentially transforming infectious disease diagnostics.
Despite its immense potential, microbiome analysis remains largely inaccessible to most healthcare practitioners. Current solutions are complex, expensive, and designed primarily for experts, requiring specialized bioinformatics knowledge and IT infrastructure. This hinders routine clinical adoption, limiting the ability of doctors to use microbiome-based diagnostics in patient care.
Our project addresses this challenge through MICK©, a pioneering microbiome analysis platform designed to make scientifically backed microbiome testing widely accessible to healthcare professionals.
MICK is the first platform to offer real-time, automated microbiome analysis, providing evidence-based recommendations for personalized patient care. Unlike existing solutions, MICK:
- Accurately profiles the microbiome, extracting critical insights from sequencing data
- Translates results into patient-specific treatment suggestions, considering phenotypic and genetic factors
- Automates analysis workflows, eliminating the need for coding skills or advanced bioinformatics expertise
- Operates seamlessly across different sequencing technologies, ensuring flexibility and broad adoption
- Supports multiple microbiome types, going beyond traditional gut microbiome testing
- Allows accurate identification of Class B pathogens (IVDR module)
By leveraging cutting-edge microbiome science, MICK contributes to tackling some of the most pressing healthcare challenges in Europe. MICK was developed to:
1.Make microbiome analysis accessible to healthcare professionals, thereby expanding the use of targeted preventive medicine.
2.Bridge the gap between microbiome research and clinical practice, bringing scientific advances from the lab to patient care.
3.Reduce health disparities by enabling wider adoption of microbiome-based diagnostics, improving global health and longevity.
MICK is designed to be used by healthcare professionals, particularly doctors, geneticists, and clinical researchers . By simplifying and democratizing microbiome science, MICK empowers physicians to integrate microbiome-based diagnostics into routine medical practice, enhancing clinical decision-making, particularly for complex conditions.
During the EIC Accelerator project, MICK advanced into a robust, validated platform for real-world clinical use. Efforts focused on enhancing bioinformatics, clinical validation, and regulatory compliance, achieving project objectives.
A key milestone was the enhancement of MICK’s metagenomics analysis algorithms. The platform was optimized to:
- Improve microbiome profiling accuracy, enabling precise identification of bacteria, archaea, fungi, yeasts, and parasites across multiple microbiome types.
- Enhance dysbiosis detection, allowing healthcare professionals to identify microbial imbalances and assess their impact on patient health.
- Implement targeted recommendations, translating microbiome data into clinically relevant, patient-specific insights.
- Transition from a monolithic system to a modular and scalable architecture to ensure seamless integration of future microbiome targets.
MICK’s scientific rigor and clinical performance were confirmed through extensive validation studies, including:
- Dysbiosis profiling and stratification, ensuring microbiome analysis aligns with clinical guidelines.
- IVDR-compliant validation of MICK Clinical (pathogen detection module), confirming its diagnostic accuracy and robustness.
- Real-world pilot studies conducted in collaboration with leading hospitals, assessing MICK’s effectiveness in dysbiosis assessment in different clinical conditions.
Furthermore, to ensure MICK’s seamless integration into clinical workflows, the platform clinical module underwent extensive regulatory preparation, including compliance with IVDR (In Vitro Diagnostic Regulation) standards , technical documentation and risk analysis completion, as well as full implementation of ISO 13485 and further certification, ensuring adherence to international medical device quality standards.
A key milestone was the enhancement of MICK’s metagenomics analysis algorithms. The platform was optimized to:
- Improve microbiome profiling accuracy, enabling precise identification of bacteria, archaea, fungi, yeasts, and parasites across multiple microbiome types.
- Enhance dysbiosis detection, allowing healthcare professionals to identify microbial imbalances and assess their impact on patient health.
- Implement targeted recommendations, translating microbiome data into clinically relevant, patient-specific insights.
- Transition from a monolithic system to a modular and scalable architecture to ensure seamless integration of future microbiome targets.
MICK’s scientific rigor and clinical performance were confirmed through extensive validation studies, including:
- Dysbiosis profiling and stratification, ensuring microbiome analysis aligns with clinical guidelines.
- IVDR-compliant validation of MICK Clinical (pathogen detection module), confirming its diagnostic accuracy and robustness.
- Real-world pilot studies conducted in collaboration with leading hospitals, assessing MICK’s effectiveness in dysbiosis assessment in different clinical conditions.
Furthermore, to ensure MICK’s seamless integration into clinical workflows, the platform clinical module underwent extensive regulatory preparation, including compliance with IVDR (In Vitro Diagnostic Regulation) standards , technical documentation and risk analysis completion, as well as full implementation of ISO 13485 and further certification, ensuring adherence to international medical device quality standards.
Accurate Microbiome Profiling & Evidence-Based Recommendations: MICK delivers precise microbiome profiles, detects dysbiosis, and provides targeted interventions like diet and probiotics. Its Dysbiosis module meets top bioinformatics and reporting standards, integrating curated databases, personalized recommendations, and strict quality control for reliable microbiome-based diagnostics.
Pathogen Detection & Insights: MICK enables high-spectrum pathogen detection, aiding in pathogenesis and antimicrobial resistance analysis. Its Clinical module for gastrointestinal infections showed 96.2% sensitivity and 100% specificity in validation, proving its accuracy as a cutting-edge diagnostic tool.
Disease-Associated Signatures: MICK incorporates the Gut Microbiome Health Index (GMHI)to identify disease-linked microbiota signatures and new biomarkers relevant to patient health.
The company has secured equity capital to drive commercialization and marketing. The next focus is international expansion through strategic partnerships and distribution channels across Europe and beyond to accelerate adoption in clinical settings.
Pathogen Detection & Insights: MICK enables high-spectrum pathogen detection, aiding in pathogenesis and antimicrobial resistance analysis. Its Clinical module for gastrointestinal infections showed 96.2% sensitivity and 100% specificity in validation, proving its accuracy as a cutting-edge diagnostic tool.
Disease-Associated Signatures: MICK incorporates the Gut Microbiome Health Index (GMHI)to identify disease-linked microbiota signatures and new biomarkers relevant to patient health.
The company has secured equity capital to drive commercialization and marketing. The next focus is international expansion through strategic partnerships and distribution channels across Europe and beyond to accelerate adoption in clinical settings.