HTG Molecular Diagnostics has obtained ISO 13485:2003 certification for the design, manufacture, and distribution of its patented qNPA technology-based products and services used in the analysis of gene expression.
qNPA molecular technology platform is designed for detecting changes in gene expression levels of formalin-fixed paraffin-embedded tissue.
HTG Molecular Diagnostics regulatory affairs and quality systems vice president Sam Rua said, "The achievement of the ISO 13485:2003 certification demonstrates HTG Molecular Diagnostics' commitment to quality and attention to detail in the development and provision of qNPA technology-based products and services, laying a solid foundation for the future growth of HTG's clinical diagnostics business."
The company is involved in providing products for gene expression profiling, miRNA and mRNA measurement for clinical research, early drug discovery companion diagnostic and prognostic applications in oncology.
