Predicine Announces Collaboration with Janssen to Develop PredicineCARE™ as a Companion Diagnostic Assay in Localized Bladder Cancer

Collaboration Utilizing PredicineCARE™ Urine cfDNA NGS Assay Marks Progress in Employing Comprehensive Genomic Profiling for Detection of Select Alterations in Localized Bladder Cancer

HAYWARD, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Predicine, Inc., a leading molecular insights company, today announced a collaboration with Janssen Pharmaceutica NV (Janssen), a Johnson & Johnson company. This collaboration focuses on the development of the PredicineCARE™ urine cell-free DNA (cfDNA) next-generation sequencing (NGS) assay as a companion diagnostic to identify patients who may benefit from targeted therapy.

PredicineCARE™ received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration on August 23, 2022. PredicineCARE™ is a comprehensive, state-of-the-art NGS assay that interrogates point mutations/indels, fusions, amplifications, and gene deletions in key cancer-associated genes using cfDNA in urine.

Dr. Shidong Jia, Predicine’s Founder, Chairman, and CEO, said in a statement, “We are delighted to collaborate with Janssen to develop a cfDNA urine-based assay designed to identify patients with localized bladder cancer who may harbor select alterations and may benefit from targeted therapy.”
About PredicineCARE™ Urine cfDNA Assay
The PredicineCARE™ Urine cfDNA assay is a targeted NGS test that enables detection of genomic alterations, including single nucleotide variants (SNVs), insertions and deletions (Indel), fusions, and copy number variations in urine cfDNA. It is a capture-based assay, which is specifically designed to detect genomic alterations of key cancer relevant genes from urine cfDNA.

About Predicine 
Predicine is a leading molecular insights company committed to advancing precision medicine in oncology. Our commitment lies in developing proprietary technologies for cell-free DNA and cell-free RNA liquid biopsy, empowering minimally invasive molecular diagnoses across various stages of disease management, including treatment selection, therapy response assessment, minimal residual disease (MRD) monitoring, and early cancer detection. The Predicine portfolio comprises state-of-the-art blood, urine, and tissue-based Next-Generation Sequencing (NGS) assays designed for harmonized global use in research, clinical investigation, and companion diagnostic (CDx) development. With operational hubs in Silicon Valley, Houston, Chicago, Shanghai, Beijing, and Suzhou, Predicine collaborates with leading biopharma companies, institutions, and governments in personalized healthcare on a global scale. For more information, please visit us on and follow us on LinkedIn or Twitter (X).

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Predicine, Inc.