Predicine Initiates FDA Premarket Approval Application for Bladder Cancer Companion Diagnostic
Key Insights
Predicine (search) has submitted the first module of a premarket approval application to the FDA for PredicineCARE (search), a urine cell-free DNA next-generation sequencing assay for use as a companion diagnostic in bladder cancer.
The comprehensive cfDNA assay targets variants in over 152 genes and can analyze DNA from blood, urine, and tissue samples with a 10-day turnaround time for results.
PredicineCARE (search) received breakthrough device designation from the FDA in August 2022 and is being developed in collaboration with Janssen, a Johnson & Johnson company.
Predicine (search), Inc has initiated a premarket approval (PMA) application with the FDA for their urine cell-free DNA (cfDNA) next-generation sequencing (NGS) assay PredicineCARE (search) for use as a companion diagnostic in bladder cancer. The molecular insights company submitted the first module of the PMA application on September 2, 2025, marking a significant regulatory milestone in the development of non-invasive cancer diagnostics.
Comprehensive Manufacturing Documentation Submitted
The first module encompasses comprehensive documentation of Predicine (search)'s manufacturing and quality management systems. According to the company, "This foundational submission is designed to support CDx development of future indications for Predicine's liquid biopsy and tissue-based assays."
Subsequent modules for the PredicineCARE (search) bladder cancer indication will be submitted in phases following completion of the registrational trial, in alignment with regulatory requirements. The company plans to submit additional modules of the application following the completion of the registrational trial of PredicineCARE.
Advanced NGS Technology Platform
The PredicineCARE (search) cfDNA assay is a comprehensive CLIA-validated assay that targets variants in 152+ genes, including single nucleotide variants (SNVs), insertions and deletions (indels), DNA re-arrangements (fusions), and copy number variations (CNVs) that are known to be clinically relevant. The test works by analyzing DNA in blood, urine, and tissue samples to detect tumor-associated genetic alterations and provide comprehensive molecular insights into tumor biology.
The capture-based assay is specifically designed to detect genomic alterations of key cancer relevant genes from blood and urine cfDNA. The average turnaround time for results is 10 days, offering clinicians timely access to critical molecular information for treatment decision-making.
Regulatory Recognition and Industry Collaboration
PredicineCARE (search) received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration on August 23, 2022. The cfDNA assay is being developed in collaboration with Janssen, a Johnson & Johnson company, highlighting the pharmaceutical industry's investment in companion diagnostic development.
"This milestone demonstrates Predicine (search)'s capabilities to develop companion diagnostics on the foundation of an FDA-grade quality and manufacturing system," said Dr. Shidong Jia, Founder and CEO of Predicine. "It reflects our team's expertise and commitment to bringing innovative, non-invasive testing solutions to patients and physicians worldwide."
Expanding Diagnostic Portfolio
In addition to PredicineCARE (search), Predicine (search) offers a portfolio of genomic profiling assays across a range of tumor types, including metastatic prostate cancer. The company positions itself as a global molecular insights company committed to advancing precision medicine through innovative liquid biopsy and tissue-based genomic testing solutions.