The Mimix™ OncoSpan FFPE reference standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from human cancer cell lines, containing more than 380 variants across 152 cancer genes. It is intended for qualitative and/or quantitative monitoring of next-generation sequencing (NGS) or droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations in genomic DNA (gDNA) from human samples for in vitro diagnostic use. The gDNA obtained from OncoSpan FFPE Reference Standard can be used in NGS or ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.
A material which is used to verify the performance of an assay intended to be used for genomic profiling/screening of multiple genes associated with cancer to detect specific types of mutations [e.g., single nucleotide variants (SNVs), insertions, deletions, fusions, translocations and/or copy number variations (CNVs)] in a clinical specimen.