New paper in Virchows Archiv: “External quality assessment (EQA) for tumor mutational burden: results of an international IQN path feasibility pilot scheme”

External quality assessment (EQA) for tumor mutational burden: results of an international IQN path feasibility pilot scheme Tumor mutational burden (TMB) has recently been approved as an agnostic biomarker for immune checkpoint inhibitors. However, methods for TMB testing have not yet been standardized. The International Quality Network for Pathology (IQNPath) organized a pilot external quality read more…

Tumor mutation burden testing: a survey of the International Quality Network for Pathology (IQN Path)

Tumor mutation burden testing: a survey of the International Quality Network for Pathology (IQN Path) Fenizia, F., Wolstenholme, N., Fairley, J.A. et al. Virchows Arch (2021). You can access the article here: https://rdcu.be/ciMl7 Abstract While tumour mutation burden (TMB) is emerging as a possible biomarker for immune-checkpoint inhibitors (ICI), methods for testing have not been standardised as yet. read more…

Update on the project
 Tumor Mutation Burden (TMB): from Recommendations for Testing to EQA Schemes


Conflicting results have been reported on the potential role of Tumor Mutational Burden (TMB) as predictive biomarker for immune checkpoint inhibitors. However, the recent approval of TMB as agnostic biomarker for pembrolizumab in previously treated patients with solid tumors is increasing the interest of laboratories to provide this test. In this scenario, the harmonization of read more…

SeraCare to Develop NGS Standards for Tumor Mutational Burden Monitoring

This article was originally published on http://www.clpmag.com/2019/04/seracare-develop-ngs-standards-tumor-mutational-burden-monitoring/ 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 read more…

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

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 read more…