SeraCare Launches New QC Software for Clinical Laboratories Running Next-Generation Sequencing Assays

MILFORD, Mass., July 26, 2016 /PRNewswire/ — SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today that the company’s precision medicine business unit has launched a groundbreaking new laboratory QC software specifically for clinical laboratories running next-generation sequencing (NGS)-based assays. The iQ NGS QC Management Software is a cloud-based software tool, designed to help labs easily track, trend, and report all their labs’ NGS QC metrics for CAP CLIA audits.

Many clinical laboratories are rapidly adopting NGS-based methods due to the tremendous amounts of data they provide, as well as unique capabilities compared to previous methods such as detection of low allele frequency variants. This grants increased utility to direct treatment for the patient in applications such as oncology and infectious diseases. However, NGS workflows can be complex, with many different QC metrics that need to be tracked, organized, and easily accessed to ensure the accuracy of the results, and to monitor the performance of the assay over time.

The iQ NGS QC Management Software is an easy to implement tool that allows labs to centralize all their QC metrics in a single, easy to access location. Using the software, labs can rapidly generate QC performance reports, including Levey-Jennings charts for any tracked variant. It flexibly conforms to any laboratory QC workflow and can help prevent errors by allowing labs to flag out of spec readings on QC materials, instruments, and reagents.

Preparing for audits and inspections or troubleshooting sub-optimal performance take up valuable laboratory time and resources. By centralizing all the relevant QC performance metrics through the entire workflow, the iQ NGS QC Management Software permits labs to rapidly assemble all necessary data in minutes instead of days. Moreover, it also provides a powerful interactive troubleshooting visualization that helps labs efficiently identify a workflow or component that generated an unexpected result.

“We are so excited to introduce this powerful new software tool to our clinical laboratory partners running NGS-based assays,” says Russell Garlick PhD, Chief Scientific Officer at SeraCare. “It is as simple as dragging a VCF file from a QC run into the software. In addition, this software perfectly complements our Seraseqâ„¢ NGS reference material product lines and provides laboratories a simple yet powerful means to efficiently manage all their QC metrics. We believe the iQ NGS QC Management Software will significantly improve how labs manage their NGS QC data and performance.”

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 provide assurance of 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).