SeraCare Life Sciences and ArcherDX are announcing at the AMP Annual Meeting a partnership on the development and commercialization of highly multiplexed RNA fusion reference materials that 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 are enabling highly multiplexed workflows to detect fusion partners from tumor specimens using their proprietary Anchored Multiplex (AMP) chemistry, which does not require prior knowledge of the breakpoint or fusion partner. A challenge for laboratories using these assays has been obtaining sufficient number and quality of rare and hard-to-find RNA gene fusion mutations for their validation and laboratory QC studies. SeraCare has developed the highly multiplexed Seraseq™ engineered FFPE cell-line technology precisely to address the lack of important and actionable patient-like fusion variant specimens.
"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," says Dale Yuzuki, MA, MEd, Director of Market Development, Oncology at SeraCare. "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."
"Finding residual samples is very difficult and time-consuming, and the variability of RNA expression varies greatly between genes and tissue types," says Jason Amsbaugh, MBA, Director of Global Marketing at ArcherDX. "Having full-process FFPE material like this with rare, hard-to-find mutations like NTRK3 and EGFR variant III helps ensure that our customers are able to find multiplex reference materials to run with our multiplex fusion assays. We are pleased to be working with SeraCare given their expertise in providing these high-complexity materials to aid our development efforts."
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