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Provide an out-of-the-box informatics solution that reduces complexity for your customers and automatically provides them with an actionable clinical genomics report using our regulatory approval ready, IVD-compliant software and knowledgebase.
Pair your NGS IVD assay with the richest source of rationalized medical interpretations and expertly curated genomic data, clinical practice guidelines, FDA/EMA approved therapies, and clinical trials. While most other vendors provide a variant lookup table, our rules-based knowledgebase, which provides automatic classifications, ready-to-use interpretations, and support for all variant types, is an ideal combination of technology and human expertise to ensure that the clinical genomic report for your IVD assay is best in class.
Provide the most accurate and comprehensive report via a regularly updated, IVD-ready knowledgebase based on the latest practice guidelines, genetic variant database content, expertly authored interpretations, and clinical trials information. This content is regularly updated using validated SOPs that are in compliance with ISO 13485 and FDA guidance regarding maintenance of genetic variant databases.
Minimize the risky process of commercializing your assay by working with a partner -- PierianDx -- who has the experience of working with regulatory agencies and other assay vendors to commercialize regulatory approved reporting solutions for their assays.
Allay concerns regarding privacy and security based on the PierianDx approach to information security, with well-established and robust policies based on regulations most relevant to the healthcare industry, including HiTRUST, HIPAA, CLIA, CAP, and GDPR. PierianDx has the capability to offer either local or on-premise solutions which can also integrate your bioinformatics or secondary analysis workflows.