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The company plans to show new data for its Signatera oncology test at three upcoming conferences this year, including in breast cancer and bladder cancer.
Startup Prophet Genomics plans to commercialize the assay, dubbed Urine Exfoliated Cells Copy Number Aberration Detector, for early detection and monitoring of patients.
Under the LCD, oncology biomarkers must have proven clinical validity and there must be acceptance of specific testing into patient management.
The test leverages a novel cancer biomarker that may improve the accuracy and sensitivity of noninvasive bladder cancer testing.
Sienna said that Unilabs, a commercial lab in Sweden, is evaluating its hTERT bladder cancer test for routine use.
The firm expects to launch a 510(k)-cleared version of its Bladder EpiCheck recurrence assay early next year followed by an RUO early-stage lung cancer assay.
The platform was used to subtype patients in a Phase II trial and found that patients in the claudin-low subgroup had the best two-year progression-free survival on pembrolizumab.
The deal marks the 10th distribution agreement Australia-based Sienna has signed for its test, including one covering Finland earlier this year.
The firm recently published a study describing three assays for prostate cancer and reporting their sensitivity and specificity in case-control cohort.
Sienna will provide sales, marketing, and technical support training to Immuno Diagnostics staff, as well as establish a reference lab.