SeraCare to Develop NGS Standards for Tumor Mutational Burden Monitoring
SeraCare Life Sciences, Milford, Mass, a provider of quality control materials for the infectious disease testing and next-generation sequencing (NGS) markets, has been selected as a technology partner in support of the first-ever external quality assessment program for tumor mutational burden monitoring, which is being developed by the International Quality Network for Pathology (IQN Path).
Under its agreement with IQN Path, SeraCare will develop, manufacture, and supply a range of highly characterized cell line genomic DNA and formalin-fixed, paraffin-embedded standards with confirmed low, mid, and high levels of mutational burden within their exome regions. Beginning in June 2019, the materials will be sent to about 30 labs as part of IQN Path’s external quality assessment program for clinical labs that are monitoring tumor mutational burden in conjunction with their NGS assays for cancer tumor profiling.