{"id":13908,"date":"2026-04-09T08:31:07","date_gmt":"2026-04-09T08:31:07","guid":{"rendered":"https:\/\/www.sequentiabiotech.com\/?post_type=new-and-event&p=13908"},"modified":"2026-05-18T08:19:44","modified_gmt":"2026-05-18T08:19:44","slug":"sequentia-biotech-achieves-ce-ivd-marking-under-ivdr-for-mick-clinical-its-new-gastrointestinal-pathogens-diagnostic-solution","status":"publish","type":"new-and-event","link":"https:\/\/www.sequentiabiotech.com\/it\/new-and-event\/sequentia-biotech-achieves-ce-ivd-marking-under-ivdr-for-mick-clinical-its-new-gastrointestinal-pathogens-diagnostic-solution\/","title":{"rendered":"Sequentia Biotech achieves CE-IVD marking under IVDR for MICK Clinical\u2122, its new gastrointestinal pathogens diagnostic solution"},"content":{"rendered":"

The new CE-IVD marked <\/b>bioinformatics<\/b> software enables microbiology labs to deliver clinically validated reports under the latest EU regulatory standards.<\/b><\/h2>\n

BARCELONA, Spain, April 9\u00a02026<\/strong> \u2013 Sequentia Biotech, a leading Spanish omics company, today announced the launch of<\/span> MICK Clinical\u2122<\/span><\/a>, the first diagnostic platform for key gastrointestinal bacteria screening to obtain the CE-IVD mark under the IVDR regulation (EU 2017\/746). This tool enables laboratories to <\/span>automate microbiological diagnostics<\/span><\/a> using Next-Generation Sequencing (NGS) data, integrating into existing workflows to accelerate medical decision-making.<\/span><\/p>\n

Managing gastrointestinal infections requires agile identification for patient care. MICK Clinical\u2122 addresses this need by automating the bioinformatics pipeline for NGS data, converting genomic complexity into reproducible results. By consolidating microorganism analysis into a detailed report, the platform supports the clinical management of symptomatic patients from an early stage.<\/span><\/p>\n

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Clinical Validation and Diagnostic Performance<\/b><\/h3>\n

In a clinical research study conducted at the Vall d\u2019Hebron University Hospital<\/b> in coordination with the <\/b>Vall d\u2019Hebron Research Institute <\/b>(VHIR)<\/b> (Barcelona), MICK Clinical\u2122 demonstrated <\/span>high diagnostic performance<\/b>, achieving <\/span>91.7% sensitivity<\/b> and <\/span>99.5% specificity<\/b>. These metrics, validated within one of Europe\u2019s leading clinical environments, provide a robust foundation for safe medical decision-making and standardized clinical practice.<\/span><\/p>\n

“This achievement reflects our commitment to creating tools that meet the highest European regulatory standards. With MICK Clinical\u2122, we are making microbiome genomics a reality in standardized clinical practice,” <\/span><\/i>says <\/span>Walter Sanseverino<\/strong>, CEO of Sequentia Biotech.<\/span><\/i><\/p>\n

Isabelle de Cremoux, CEO and Managing Partner of Seventure Partners<\/strong>,<\/strong> highlights the importance of this milestone for the market:<\/span>
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\n<\/span>\u201c<\/span>This CE-IVD achievement marks a critical transition from innovation to clinical adoption. The diagnostic performance validated <\/span><\/i>at the Vall d\u2019Hebron University Hospital<\/i><\/b> proves MICK Clinical\u2122 can deliver real clinical value. As investors, we’re thrilled to see Sequentia translating genomic complexity into a trusted tool that clinicians can rely on\u2014that’s where the real impact happens.<\/span><\/i>“<\/span><\/p>\n

Regulatory Context: Setting a New Standard under IVDR<\/b><\/h3>\n

The transition from the previous IVDD to the more rigorous <\/span>In Vitro Diagnostic Regulation (EU 2017\/746)<\/strong> represents a major shift in European clinical diagnostics. While many bioinformatics tools currently operate as Research Use Only (RUO), MICK Clinical\u2122 has been developed as a certified<\/span> Medical Device Software (MDSW)<\/b>. By securing the CE-IVD mark under IVDR, Sequentia Biotech ensures that its NGS-based screening meets the highest levels of clinical evidence and patient safety mandated by the new EU framework.<\/span><\/p>\n

Commitment to Quality: ISO 13485 Certification<\/b><\/h3>\n

Sequentia Biotech holds ISO 13485 Certification, an international standard that affirms a stringent Quality Management System (QMS) instituted to guarantee traceability and safety within the medical device sector. <\/span><\/p>\n

About Sequentia Biotech:<\/strong> Sequentia Biotech is an <\/span>ISO 13485 certified<\/b> leader in bioinformatics, developing software and services to drive innovation in research and healthcare through advanced multi-omics analysis.<\/span>
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\n<\/span>For more information or to request a demo, contact us<\/a><\/span>
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Media Contact:<\/b><\/p>\n