Cell-line Derived Controls for Diagnostic Assay Development

Amsbio announce the addition of mutation cell line Formalin-Fixed Paraffin-Embedded (FFPE) samples and isolated genomic DNA (gDNA) controls to its extensive range of cell line reference standards.

In both routine clinical use and diagnostic assay development, biologically-relevant positive and negative controls represent an invaluable resource. To ensure accuracy and reproducibility during IVD assay development and established diagnostic tests, reference standards for genomic DNA analysis and Immunohistochemistry (IHC) assays are an essential tool. However reliable sources of reference material for rarer genetic profiles remain a constant challenge.

IsoMax™ reference standards have been accurately engineered to model the genetics of specific patient populations in vitro. These unique new reference standards can be directly incorporated into sample processing workflows for assay optimisation, evaluation of sensitivity and specificity as well as monitoring the impact of workflow changes on downstream analysis.

Building on the CellMax™ range of more than 50 well-known cancer cell line FFPE controls, IsoMax™ reference standards provide a renewable source of control material for recognised mutations in cancer markers. Based on CRISPR/Cas9 isogenic cell lines, a wide range of mutations are offered from target genes, including EGFR, KRAS, BRAF, and PIK3CA.

Available in multiple formats, including FFPE blocks, slides, scrolls, and isolate gDNA, IsoMax™ and CellMax™ standards provide an inexhaustible supply of consistent positive and negative controls.