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Predicine, Janssen to Collaborate on Bladder Cancer CDx

NEW YORK – Predicine said on Monday it has signed a collaboration agreement with Janssen Pharmaceuticals to develop a urine-based assay as a companion diagnostic to identify bladder cancer patients who would benefit from targeted therapies.

Financial and other terms of the agreement were not disclosed. Specific therapies that the assay is being developed for were also undisclosed.

Hayward, California-based Predicine said its PredicineCare next-generation sequencing-based (NGS) assay is used to detect in cell-free DNA alterations to cancer-relevant genes including single nucleotide variants, insertions, and deletions, fusions, and copy number variations. The firm also secured in August 2022 a CE-IVD mark for PredicineCare as a blood and urine cfDNA assay that can target 152 genes that are actionable and linked with available therapies or those in clinical trials.

The firm noted Monday that it also received in August 2022 US Food and Drug Administration breakthrough device designation for the PredicineCare assay. It said its NGS assays are designed for use in research, clinical investigation, and companion diagnostic development.