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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.

If the team is successful in expanding on the results that they reported last month, it could open a new application for the still nascent circulating tumor DNA technology.

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

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.

Laboratory staffing and supply shortages limited patient access to cancer screening tests, and the pandemic decreased the development and validation of new tests.