Premarket approval application initiated with FDA for companion diagnostic in bladder cancer

Predicine, Inc has initiated a premarket approval (PMA) application with the FDA for their urine cell-free DNA (cfDNA) next-generation sequencing (NGS) assay PredicineCARE for use as a companion diagnostic in bladder cancer.¹

Specifically, the company has submitted the first module of the PMA application, which includes comprehensive documentation of Predicine’s manufacturing and quality management systems. The company noted, “This foundational submission is designed to support CDx development of future indications for Predicine’s liquid biopsy and tissue-based assays.”

The company also reported plans to submit additional modules of the application following the completion of the registrational trial of PredicineCARE. These subsequent modules will be submitted in phases.

“This milestone demonstrates Predicine’s capabilities to develop companion diagnostics on the foundation of an FDA-grade quality and manufacturing system,” said Shidong Jia, MD, PhD, founder and CEO of Predicine, in the news release from the company.¹ “It reflects our team’s expertise and commitment to bringing innovative, non-invasive testing solutions to patients and physicians worldwide.”

According to the company, “The PredicineCARE 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.”² 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 average turnaround time for results is 10 days.³

The FDA previously granted a breakthrough device designation to PredicineCARE in August 2022. The cfDNA assay is being developed in collaboration with Janssen, a Johnson & Johnson company.

In addition to PredicineCARE, Predicine offers a portfolio of genomic profiling assays across a range of tumor types, including metastatic prostate cancer.

REFERENCES

1. Predicine submits first module of PMA application to FDA for PredicineCARE as a companion diagnostic assay in bladder cancer. News release. Predicine, Inc. September 2, 2025. Accessed September 2, 2025. https://www.globenewswire.com/news-release/2025/09/02/3142717/0/en/Predicine-Submits-First-Module-of-PMA-Application-to-FDA-for-PredicineCARE-as-a-Companion-Diagnostic-Assay-in-Bladder-Cancer.html

2. Predicine’s liquid biopsy next-generation sequencing (NGS) assay is granted breakthrough device designation by U.S. Food and Drug Administration. News release. Predicine, Inc. September 20, 2022. Accessed September 2, 2025. https://www.globenewswire.com/news-release/2022/09/20/2519289/0/en/Predicine-s-Liquid-Biopsy-Next-Generation-Sequencing-NGS-Assay-is-Granted-Breakthrough-Device-Designation-by-U-S-Food-and-Drug-Administration.html

3. Clinical Trials. Predicine. Accessed September 2, 2025. https://www.predicine.com/solutions-overview/