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The Rehovot, Israel-based firm expects to soon receive marketing clearance from the US Food and Drug Administration for its methylation-based Bladder EpiCheck test.
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 said that a Series A round of financing will enable it to begin marketing its Urodiag test for recurrent bladder cancer.
During a conference call, company executives also discussed results from the SMART NIPT trial and their outlook for Natera's three businesses.
The firms will present a clinical comparison study using the workflow to detect FGFR mutations in 50 urothelial cancer patients later this year.
Earlier this year, Novigenix and collaborators were awarded up to €1 million to develop a blood-based multi-omics colorectal cancer assay.
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.