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In Brief This Week: Agendia and MolecularMD

NEW YORK (360Dx) – Agendia said this week that US Oncology has joined its FLEX breast cancer registry study. The study is a large-scale, prospective, observational cancer study that links full genome profiling with clinical data to create a patient database that could be used to identify new gene associations with prognostic and/or predictive value in breast cancer. All US Oncology Research-affiliated sites can participate in FLEX with eight initial sites in Texas and Arizona open for enrollment.

The first milestone for FLEX, which includes Agendia’s MammaPrint and BluePrint molecular subtyping tests, will be to capture genomic and clinical data for 10,000 breast cancer patients with 10 years of follow-up. The study is open to women and men in the US who have been diagnosed with stage I, II, or II cancer. Since enrollment began last year, 45 centers in the US have joined FLEX, and more than 700 patients have been recruited for the study, Agendia said.

MolecularMD said this week that it has validated Thermo Fisher Scientific’s Oncomine Tumor Mutation Load Assay for clinical research trials for immunotherapy drug development. The assay interrogates 409 cancer-related genes and correlates well with exome mutation counts. MolecularMD has also developed an alternative workflow and quality control method to address deamination errors, which may result in inflated tumor mutational burden (TMB). The company offers the assay to customers as a service for translational research and clinical trials and is working on additional studies to determine the clinical utility of TMB analysis for predicting patient response to checkpoint inhibitors.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.