Charlotte, NC and Milford, MA, November 9, 2016 - 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.
"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."
The Seraseq FFPE Tumor Fusion RNA Reference Material v2 will available to ArcherDX's customers later this month. 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 to be used in the same way as a tumor-tissue sample.
ArcherDX addresses the bottlenecks associated with using NGS in translational research by offering a robust platform for targeted sequencing applications. Archer's targeted NGS assays generate highly enriched sequencing libraries to detect gene fusions, SNVs, indels and CNVs. Accompanied by the Archer Analysis suite of bioinformatics software, Archer's technology dramatically enhances complex mutation identification and discovery.
With product portfolios encompassing applications in gene fusions, DNA copy number, immune repertoire profiling, and liquid biopsy research, ArcherDX continues to lead in the development of high-impact applications in cancer research.
For more information, visit http://ArcherDX.com/
Note: Archer kits and analysis software are for research use only and not for use in diagnostic procedures.
About SeraCare Life Sciences Inc.
SeraCare enables the promise of precision medicine by advancing the understanding of disease and providing assurance of the diagnostic result. Our innovative tools and technologies not only ensure the safe, effective, and accurate performance of diagnostic assays but also establish a framework for regulating, compiling, and interpreting data from precision diagnostics. Our portfolio includes a broad range of products such as quality control technologies, disease-state specimens and tissues for research and development, processed biological materials, and immunoassay reagents. For more information, please visit www.seracare.com and follow SeraCare on Twitter (@SeraCare).