I2I phase I: assessment of genotypic markers for profiling of circulating tumor cells

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Current cancer staging methods are not broadly effective when applied to predicting tumor prognosis and response to therapy, driving the need for specific tumor characterization approaches. Two aspects which confound the ability to predict tumor prognosis and assign appropriate therapies are the heterogeneous nature of cancers and the difficulty of identifying metastases in a timely manner. A promising approach that may serve to address these problems is the analysis of Circulating Tumour Cells (CTCs). As the CTCs are shed from the primary tumour itself, these rare cells can provide a means to re-characterize a tumour during treatment without the need for continual re-biopsy. This can be particularly powerful when assessing CTC phenotype to understand disease aggressiveness, or CTC genotyping for applications in precision medicine. To this date, technologies being developed for CTCs focus on capture and enumeration of these rare cells and rely on off-chip assays for assessment of CTC population phenotypes and genotypes. Thus, a single solution is not available for characterization of CTCs within a patient's blood sample with the goal of developing a "liquid biopsy" to inform treatment decisions. **In response to a need for technology to simultaneously capture and molecularly characterize a CTC population, we have developed a new technology - Magnetic Ranking Cytometry (MagRC) - that enables CTC profiling at the level of protein and mRNA expression. This approach uses a new type of microfluidic device that sorts the cells into different capture zones according to the number of nanoparticles bound, and can measure expression levels calculated by the location of the cells within the device. The proposed project aims to rigorously validate this technology, assess manufacturability of assay consumables, and develop the necessary companion technologies for assay automation. ****