Tanja Obradovic: Testing is critical in order to support current treatment options for cancer patients
Tanja Obradovich shared on LinkedIn:
“Testing is critical in order to support current treatment options for cancer patients so just published recommendations for tumor mutational burden (TMB) assay validation and reporting is a great service to patients and all Oncology care stakeholders.
A Joint Consensus Recommendation of the Association for Molecular Pathology, College of American Pathologists, and Society for Immunotherapy of Cancer was a result of deliberation performed by exceptional team of experts.
It comprised of thirteen participants from the United States and one from Europe who represented molecular pathologist, molecular geneticist, pathologist, oncologist, and bioinformatician expertise and experience in NGS testing for TMB.
TMB is defined as the total number of nonsynonymous somatic mutations per megabase of coding DNA sequenced and current practice is characterized by substantial variations in how TMB is calculated, reported, and interpreted due to wide-spread use of laboratory-specific assay features.
Some including the genomic size of the territory from which it is calculated, gene content of the assay, whether somatic only or paired tumor-germline sequencing is performed, algorithmic components and settings of bioinformatic pipelines, inclusion or exclusion of specific variant types from the calculation, and other analytical methods used to adjust or normalize the data, all of which ultimately together with pre-analytical variability can compromise patient data validity.
Absolutely great step toward improved cancer patient care as well as implications for hundreds of ongoing and planned clinical trials that can benefit from very detailed recommendations in this publication.
Source: Tanja Obradovich/LinkedIn
Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.