International expert group focused on improving quality of clinical biomarker testing launching pilot TMB
proficiency program in Spring 2019
MILFORD, Mass., WED. March 27, 2019 /PRNewswire/ — 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 next-generation sequencing (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.
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).