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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.
Natera discussed its cancer and transplant rejection testing businesses, while Exact Sciences explained how it will benefit from its Genomic Health acquisition.
Kindstar has also agreed to purchase Genesis systems for use by its scientists to monitor circulating tumor cells and for single-cell research.
The British molecular diagnostics company received a CE-IVD mark for the assay, called BCA-1, in June, and launched the test in October.