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Clinical Intelligence optimizing detection of biomarkers in diverse populations of patients with can

Aster Insights, the leading provider of scientific and clinical intelligence for oncology discovery, today announced a research collaboration with the Food and Drug Administration (FDA). This multi-year research endeavor will begin with research to investigate the differences in scoring algorithms used in diagnostic tests to determine whether a patient is a suitable candidate for immune checkpoint inhibitor (ICI) therapy. The initial project will examine tumor mutational burden (TMB) in over 20,000 patients with solid tumor malignancies. TMB is a measure of the number of mutations in the DNA of a patient’s cancer cells. A greater number of mutations leads to a higher TMB and increases the likelihood that a patient with cancer may respond to ICI treatment. Current methods and algorithms guiding clinical decision-making as to whether a patient with high TMB cancer should be on an ICI is based on data that may skew toward certain patients of Northern European descent, potentially biasing results for more ethnically diverse patient populations. Together with scientists at the FDA Oncology Center of Excellence, Aster Insights will utilize its wealth of patient data to explore ethnic differences in TMB scoring based on current testing methods. The study aims to determine if a „one size fits all“ standard for assessing TMB is the best approach for predicting response to ICIs across tumor types and populations, or whether diverse populations warrant different standards. Aster Insights researchers will develop a more exact TMB to match the racial and ethnic background of each patient and enable clinicians to determine the best course of treatment on an individual basis.

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