March 2019

IQN Path Selects SeraCare Life Sciences for First-Ever Tumor Mutational Burden External Quality Assessment Program

SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today their successful selection as a technology partner in support of the first ever tumor mutational burden (TMB) external quality assessment (EQA) program being developed by the International Quality Network for Pathology (IQN Path).  Under the agreement with IQN Path, SeraCare Life Sciences will develop, manufacture, and supply a range of highly-characterized cell line genomic DNA and formalin-fixed, paraffin embedded (FFPE) standards with confirmed low, mid, and high levels of mutational burden within their exome regions. Beginning in June 2019, this material will be sent to about 30 labs as part of the first-ever EQA program for clinical labs who are monitoring TMB as part of their cancer tumor profiling assays by NGS.

Studies to understand the clinical utility of TMB as a biomarker by NGS have been hampered by the lack of available standards and cost-effective assays for laboratories to implement. Last fall, SeraCare entered this space by joining the Friends of Cancer Research consortium on TMB harmonization as a key partner and provided standards for their harmonization efforts.  Interest in TMB standards and harmonization is currently a very important topic of clinical research, as numerous pharma companies have clinical immuno-oncology (I-O) programs and seek to accurately and consistently assess TMB scores using NGS panels deployed in labs around the world in order to direct I-O therapeutics.

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

“As the leading company assisting the clinical implementation of genomic testing for cancer, SeraCare is pleased to be selected by IQNPath to support their goals of developing a first-of-its-kind global TMB proficiency program,” said Trevor W Brown, Vice President of Clinical Genomics for 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.“

“We are pleased to be working with a market leader in SeraCare for our first-ever TMB proficiency program,” said Dr. Nicola Normanno, President of IQN Path. “As more and more high-content NGS panels capable of providing a TMB score are brought to the market, the need for a common reference standard and proficiency programs to support clinical adopters becomes very important.  We are excited to be leading the effort to assess inter-laboratory performance on this important biomarker that will ultimately help clinicians make more informed treatment decisions with these new class of I-O therapeutics.”

In addition to providing TMB standard materials for the IQN Path program, SeraCare will be offering access to its custom TMB portfolio as part of its VariantFlex™ custom product and service portfolio to interested parties from the pharmaceutical and IVD sectors in the coming months.

Learn more about the SeraCare’s TMB reference standard programs here.