Tumor Mutational Burden

Tumor mutational burden (TMB) is the most promising genotyping biomarker for immuno-oncology (I-O) therapeutic response, but its application is hindered by the lack of a standardized TMB measurement by targeted NGS panels, and an absence of TMB reference materials to support these measurements. SeraCare is developing the first consensus-driven reference standard for TMB measurement to accelerate the clinical application of TMB in I-O therapeutic treatment stratification.

Global Efforts are Underway

  • SeraCare is the sole provider of materials to inform the development of TMB reference standards to Friends of Cancer Research’s TMB Harmonization Working Group; a consortium of clinical, regulatory, and industry experts working on harmonizing TMB measurements by targeted NGS panels. Now in phase two, this project aims to develop a consensus solution on how to standardize methods for calculating and reporting TMB measurement and advance patient care.

TMB chart

  • There are several planned global proficiency projects (EQA) in which SeraCare is participating as a TMB reference standard supplier.

  • We have organized and are facilitating a TMB Working Group of I-O thought leaders from NGS assay manufacturers, pharma/biopharma, cancer research and treatment hospitals, and clinical reference laboratories charged with informing the design, development, and evaluation of SeraCare-developed and manufactured reference standards for TMB measurements.

  • Seraseq® TMB reference standards are in development from WES-characterized cell lines (tumor-normal matched pairs) and will provide measurements of TMB high, intermediate, and low in targets NGS panels.

Rely on Our Expertise

SeraCare is a globally recognized leader in NGS tumor profiling reference materials and QC data management solutions. NGS panel manufacturers and clinical testing laboratories rely on our broad portfolio of highly multiplexed RNA and DNA reference standards to accelerate their assay development, validation, and clinical deployment for cancer patient testing.

And with SeraCare’s VariantFlex™ custom NGS library, you can easily get the variants you need at your desired allele frequencies in the format that fits your assay within weeks, thanks to our streamlined process and flexible biosynthetic technology.

If you’re interested in early access evaluation of our tumor mutational burden reference standards, please contact us today.

Contact Us to Get Started