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Genomics: Clinical Implementation

This channel includes news headlines and educational resources regarding the clinical implementation of genomics assays, including development, validation, quality control, standardization, and the practical and commercial considerations for labs adopting these tests. 

The firm presented evidence that its DetermaIO gene expression test can help predict which bladder cancer patients are likely to respond to immune checkpoint inhibitors.

The results represent a significant improvement over currently used screening tools and are spurring renewed LDT commercialization and regulatory submission efforts.

The company is also working on a new Saphyr system that will have 14 times higher throughput than the current one, which can analyze 5,000 human genomes per year.

The survey found analysis, interpretation, and reporting requirements can take more than six hours per test but that reimbursement for tests doesn't account for this work.

The company is collaborating with the University of Leeds under a new grant, aiming to collect prospective validation and economic data that could support clinical adoption.