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Molika Ashford covers personalized medicine and molecular diagnostics for GenomeWeb.
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 company has previously offered its liquid biopsy tests through an LDT model but sees the timing and the clinical niche as right for a regulatory bid in CSF testing.
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 plans to transition its DetermaIO test from research to clinical use and to launch a new research product for immunotherapy monitoring by the end of this year.
The firm highlighted a new study exploring immune-related gene expression in ovarian cancer and gave an update on its lead diagnostic candidate for head and neck tumors.
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.
The company plans to publish new data on clinical sensitivity and specificity and has initiated multiple studies investigating new use cases.
With its liquid biopsy test FDA approved and monitoring and screening offerings poised for launch, the firm is turning its attention to tumor tissue testing.
Investigators reported that the classifier could correctly predict cancer type with over 94 percent accuracy and highlighted impacts in a commercially tested cohort.