The materials will support the validation and routine monitoring of the Archer FusionPlex gene fusion detection kits.
NGS-based assay kits such as Archer's FusionPlex solid tumor panel enables highly multiplexed workflows to detect fusion partners from tumor specimens using their Anchored Multiplex (AMP) chemistry.
By using assays, laboratories need to obtain sufficient number and quality of rare and hard-to-find RNA gene fusion mutations for their validation and laboratory QC studies.
SeraCare developed the highly multiplexed Seraseq engineered FFPE cell-line technology to deal with the crucial and actionable patient-like fusion variant specimens.
By the end of this month, the Seraseq FFPE Tumor Fusion RNA Reference Material v2 will available to ArcherDX's customers.
Each of the 16 fusion RNAs expressed is individually quantitated by digital PCR in the GM 24385 cell lines. The cells are formalin-fixed and paraffin embedded for use in the same way as a tumor-tissue sample.
SeraCare oncology market development director Dr Dale Yuzuki said: "There is a large amount of interest in new reference materials for gene fusions as more and more labs are using RNA-based sequencing assays to detect this class of driver mutation.
"Given the highly multiplexed nature of Archer's FusionPlex assays, there is an absolute need for standard reference materials that reflect the complexity of these assays, and having 16 of the common and difficult-to-find fusion mutations in a single sample offers both in vitro diagnostic test developers and clinical testing laboratories a valuable resource."
