CHARLOTTE, N.C. and MILFORD, Mass., Nov. 9, 2016 /PRNewswire/ -- SeraCare Life Sciences, a global provider of tools supporting assay development and laboratory QC, and ArcherDX, a leading provider in next-generation sequencing-based assays, 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.
Gene fusions are increasingly important and actionable targets in many somatic tumors. 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. As an example, MET exon 14 skipping is a mutation that is present in a small percentage of lung adenocarcinoma and could be a candidate for targeted therapy. It is one of the 16 unique mutation types in SeraCare's Seraseq FFPE Tumor Fusion RNA Reference Material v2 that is assayed by Archer's FusionPlex Solid Tumor and FusionPlex CTL assays. The latest iteration of this RNA fusion standard was designed by SeraCare with specific feedback from ArcherDX's scientific team for improved compatibility with their Archer Analysis bioinformatics platform.