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SeraCare Life Sciences Announces New Highly Multiplexed Fusion RNA Assay Reference Standards

SeraCare Life Sciences, Inc. announced the launch of Seraseq™ Fusion RNA Mix v2 and Seraseq FFPE Fusion RNA Reference Material v2. The two new products are based upon feedback from leading in vitro diagnostic assay developers of NGS-based RNA fusion assays, and were built in consultation with clinical experts. The highly multiplexed mixes include 15 clinically-actionable fusion RNA partners. Two formats are offered: both purified nucleic acid (the Fusion RNA Mix) and formalin-fixed, paraffin-embedded tissue slices (FFPE Fusion RNA Reference material). The products are being launched at the Molecular Medicine Tri-conference taking place this week in San Francisco.

This updated version of the product includes additional clinically relevant tissue-specific RNA fusions implicated in solid tumors, and is critically important for labs validating and monitoring the performance of these assays. Newly added fusion partners include SLC45A3-BRAF and TMPRSS2-ERG, both common in prostate cancers, and EGFR-SEPT14, which is common in brain gliomas. These fusion RNAs are detected by commonly available NGS-based assays, such as the QIAseq Targeted RNAscan Panels.

SeraCare’s Precision Medicine business unit has previously announced collaboration on expert-designed RNA fusion reference standards.

“Reference standards are crucial components to optimize and validate the performance of NGS panels, as they allow users to validate the performance of a panel against pre-specified metrics of reproducibility, specificity, and sensitivity. The SeraSeq Fusion RNA v2 reference standard has been an optimal component in further optimizing the performance of our QIAseq RNAscan targeted panels for fusion analysis. We have been fortunate to work with SeraCare on their second iteration of this important product and look forward to future collaboration,” stated Raed Samara, Ph.D., Global product manager, NGS solutions, QIAGEN.

“Being able to source a consistent and reliable supply of rare and important RNA fusions, whose transcript levels are characterized using digital PCR technology is a major need for laboratories adopting targeted NGS-based assays,” explained Dale Yuzuki, M.A., M.Ed., Director of Market Development Oncology at SeraCare. “Our Seraseq Fusion RNA products offer labs 15 actionable, difficult, and rare RNA fusions in a single sample, providing a more comprehensive assurance of test performance with significant cost savings to the lab.”