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View case studyBring speed and clarity to gastrointestinal pathogen screening with a cloud-based CE-IVD software solution, compliant with the IVDR.
MICK Clinical is a CE-marked in vitro diagnostic (IVD) cloud software supporting laboratories and healthcare institutions with efficient screening of selected gastrointestinal microorganisms.
One workflow supports the screening of multiple selected gastrointestinal microorganisms in a single report.
No added manual workload as testing volumes increase.
Earlier insights compared to sequential testing approaches. |
Tap each category to compare methods
Limited to predefined targets (one panel at a time)
Broad, comprehensive detection of multiple pathogens in a single run
Multiple sequential tests may be needed
One workflow covers many organisms simultaneously
Reliable but can be slower if multiple tests are required
Streamlined, faster overall diagnosis process
Pathogen Coverage
Workflow Efficiency
Turnaround Time
Limited to predefined targets (one panel at a time)
Multiple sequential tests may be needed
Reliable but can be slower if multiple tests are required
Screening of key selected pathogens within a single workflow
Scales with high-throughput NGS workflows
Streamlined, faster overall diagnosis process
Easily integrates into existing NGS workflows, removing slow manual data handling.
Demonstrated an overall sensitivity of 91.7% and specificity of 99.5% in a clinical validation study.
Delivers reliable results within hours, accelerating decision-making.
Developed under GDPR framework, and hosted on ISO 27001– and SOC 2–compliant cloud infrastructure.
MICK Clinical has been clinically validated to support reliable screening of key gastrointestinal microorganisms. In a clinical validation study, the software demonstrated an overall sensitivity of 91.7% and a specificity of 99.5%, confirming its strong clinical performance.
Supports diagnosis by providing clear, standardised screening results for gastrointestinal pathogens.
Seamlessly integrates into NGS workflows using raw FASTQ data from faecal samples.
Developed and validated in accordance with Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices.
Built on recognised security standards to protect data and ensure compliance.
Our compliance with the General Data Protection Regulation (GDPR, EU 2016/679) ensures that all personal data are processed lawfully, transparently, and securely, in accordance with the highest standards of privacy and data protection.
Our accreditation according to the ISO 13485:2016 standard ensures that the design, development, production, and distribution of medical devices comply with the highest quality and safety standards.
ISO 13485:2016 Certified by Notified Body TÜV SÜD Product Service GmbH (NB 0123).
Our CE-IVD marking certifies that MICK CLINICAL comply with the European Union’s strict regulatory requirements for safety, performance, and reliability.
CE-IVD conformity assessed according to Regulation (EU) 2017/746 (IVDR). Certified by Notified Body TÜV SÜD Product Service GmbH (NB 0123).
The complexity of genomes (human and non-human), which requires exceptional analytical power.
The heterogeneity and variable quality of omics data, along with the lack of standardized protocols.
The need for robust computational tools to process the sheer volume of data from high-throughput technologies.
The difficulty of translating complex data into applicable results tailored to each stakeholder’s unique needs, which demands the highest level of scientific and technical expertise.
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