Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference Standard
Primary DI
05056850400052
Brand
Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference Standard
Company
REVVITY DISCOVERY LIMITED
Model
HD852-IVD
Catalog number
HD852-IVD
Device description
The Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl made from a multiplex of 7 engineered cell lines from the GM24385 Genome in a Bottle Consortium Cell line (GIAB), containing 5 single nucleotide polymorphisms (SNPs) and 2 gene fusions. It is intended for quantitative and/or qualitative monitoring of next-generation sequencing (NGS) or droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations and gene fusions in genomic DNA (gDNA) or RNA from human samples for in vitro diagnostic use. The gDNA or RNA obtained from Geni OncoMix 1 DNA/RNA FFPE Reference Standard can be used to monitor NGS or ddPCR workflows, 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.