Purchase of Reference Material for Calculation of Tumor Mutational Burden (TMB)

TMB measures the quantity of mutations found in a tumor. This biomarker is under study to evaluate if it may help predict the likelihood a patient with cancer will benefit from certain therapies. However, currently there is a lack of standardization for TMB calculation. Different tests report different measurements, and it is therefore difficult to use as a biomarker. To achieve consistency across tests, it is imperative to create standardization to arrive at clinically-meaningful results. Therefore, there is a need to have a standardized way of calculating and reporting TMB. Friends of Cancer Research has convened stakeholders across all health sectors to review the current methods of TMB calculation. The group has worked on collaborative analytical validation studies to support a standardized method of TMB measurement, which will help improve patient care through consistent TMB reporting despite differences in the testing assay used.

Huvudsaklig plats för byggnation/anläggning eller utförande: Scilifelab, Solna.

Under this contract we will purchase five different reference materials, each in two different formulations. We will be purchasing TMB reference samples with various TMB loads, ranging from 7 to 26. The samples will be purchased both as extracted genomic DNA, as well as formalin-fixed and paraffin-embedded material.

The material will be purchased from SeraCare (via its Swedish distributor Triolab AB) as this is a well-charactarised reference material dataset that has analysed by the member labs of the Friends of Cancer Research network, and detailed results are available in various publications (e.g., ASCO Poster #268, 2019 ASCO meeting: https://meetinglibrary.asco.org/record/172797/abstract and 2020 AACR Virtual Meeting in April 2020: https://www.focr.org/sites/default/files/AACR_2020_TMB.pdf).

No other material has been as well characterized by multiple stakeholders.

Visma notice: https://opic.com/id/aflvbfeazl