For in vitro diagnostic use. See country-specific product labeling for regulatory status. Instrument Country Specific Labeling navify Mutation Profiler IVD navify® Mutation Profiler INS_6548 09 097 821 001 9 097 821 001 09097821001 9097821001 09097821001 NAVIFY Mutation Profiler - v 2.x NAVIFY Mutation Profiler - v 2.x 07613336181331 Electronic Services Not Available Not Available navify Mutation Profiler: CE-IVD navify Mutation Profiler is a software product intended to be used as a tool in the interpretation of genomic alterations and signatures generated from sequencing DNA isolated from FFPE tumor tissue and liquid specimens from solid or hematologic malignant neoplasms. The software provides tumor mutation profiling for use in the laboratory test setting by annotating somatic alterations and mutational signatures with information curated from published literature, databases, professional medical guidelines, approved drug labels, and clinical trial databases. This information is reported with a tiered classification based on professional guidelines. The software also enables the user to implement cut-off thresholds for genomic signatures, provides approved therapeutic options and prognostic information, and generates a report. The software is not intended as a primary diagnostic tool for use by physicians or to be used as a substitute for professional healthcare advice. Each user is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditation requirements. Genomic annotations from navify Mutation Profiler are not prescriptive or conclusive for labeled use of any specific therapeutic product. navify Mutation Profiler: Other Regions navify Mutation Profiler is a software product intended to be used as a tool in the interpretation of genomic alterations and signatures generated from sequencing DNA isolated from FFPE tumortissue and liquid specimens from solid or hematologic malignant neoplasms. The software provides tumor mutation profiling for use in the laboratory test setting by annotating somatic alterations and mutational signatures with information curated from published literature, databases, professional medical guidelines, approved drug labels, and clinical trial databases. This information is reported with a tiered classification based on professional guidelines. The software also enables the user to implement cut-off thresholds for genomic signatures, provides approved therapeutic options and prognostic information, and generates a report. The software is not intended as a primary diagnostic tool for use by physicians or tobe used as a substitute for professional healthcare advice. Each user is responsible for ensuring compliance with applicable international, national, and local clinical laboratory regulations and other specific accreditation requirements. Genomic annotations from navify Mutation Profiler are not prescriptive or conclusive for labeled use of any specific therapeutic product. en

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