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.

Trevor W. Brown,  SeraCare.

Trevor W. Brown, SeraCare.

Studies to understand the clinical utility of tumor mutational burden as an NGS biomarker have been hampered by the lack of available standards and cost-effective assays. Harmonization of tumor mutational burden standards is important for current clinical research, as a number of biopharmaceutical companies require such standards in order to advance their programs in clinical immunooncology. Such research is seeking to use NGS panels to accurately and consistently assess tumor mutational burden scores, in order to guide the use of immunooncology therapeutics.

“SeraCare is pleased to be selected by IQN Path to support their goals of developing a first-of-its-kind global tumor mutational burden proficiency program,” says Trevor W. Brown, vice president for clinical genomics at SeraCare. “Our rapid and highly customizable genomic standards technologies allow us to quickly respond to the unique needs of a partner like IQN Path, while still leveraging the strong quality-focused manufacturing capabilities for which SeraCare has been historically known.”

Nicola Normanno, IQN Path.

Nicola Normanno, MD, IQN Path.

IQN Path is an international group whose mission is to facilitate the clinical implementation of tissue-based biomarkers through multistakeholder cooperation. It has a membership consisting of academic and corporate stakeholders from the pharmaceutical and in vitro diagnostics sectors.

“As more and more high-content NGS panels capable of providing a tumor mutational burden score are brought to the market, the need for a common reference standard and proficiency programs to support clinical adopters becomes very important,” says Nicola Normanno, MD, president of IQN Path. “We are excited to be leading the effort to assess interlaboratory performance on this important biomarker that will ultimately help clinicians make more-informed treatment decisions with this new class of immunooncology therapeutics.”

For further information, visit SeraCare Life Sciences.