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SeraCare, ArcherDx Partner on RNA Fusion Standards

NEW YORK (GenomeWeb) – SeraCare and ArcherDx have announced a collaboration to develop and commercialize highly multiplexed RNA fusion reference materials that will be used for validation and quality control of Archer's FusionPlex gene fusion detection kits.

The FusionPlex panels are next generation sequencing-based assay kits that do not require prior knowledge of the breakpoint of fusion partner, but labs have been challenged in finding RNA gene fusion mutations for validation and quality control.

The Seraseq FFPE Tumor Fusion RNA Reference Material v2 will be available to ArcherDx's customers later this month, the firms said. Each of the 16 fusion RNAs it contains is individually quantified in the cell lines by digital PCR, and cells are formalin-fixed and paraffin embedded so that they can be used in the same way as a tumor tissue sample.

"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," Dale Yuzuki, SeraCare's director of market development for oncology, said in a statement.

Illumina recently made an agreement for worldwide distribution of Archer's kits, and two of the assays have been conditionally approved by the New York State Department of Health.