The Role of Liquid Biopsy in the Management of Patients with Genitourinary Malignancies.

Background And Objective: Liquid biopsy testing refers to the use of specific analytical methods to detect disease-related biomarkers in blood or its components. These tests can be either qualitative or quantitative. Liquid biopsy testing is increasingly used in patient care. Here, we explore all the current Food and Drug Administration (FDA)-approved indications for liquid biopsies related to genitourinary oncology. The secondary objective is to describe a few other potential uses of this technology that may become approved soon.

Methods: We conducted a systematic review of all FDA approvals from 2015 through 2025. We interrogated multiple FDA databases to capture both tumor-specific and tissue-agnostic approvals. We limited the search to indications related to or requiring biomarker testing to assess the value of liquid biopsy testing. A total of 1119 approvals were identified. Of these, nine unique drug approvals related to genitourinary cancers require molecular testing. We then identified the registrational trials used for those approvals through PubMed and present the results here. For the secondary endpoints, we identified examples published within the past 10 yr.

Key Findings And Limitations: The current use for liquid biopsy testing based on regulatory approval is for predicting treatment response. There are nine FDA-approved drugs or drug combinations applicable to clinical practice for patients with genitourinary malignancies. Liquid biopsy testing is currently available to identify patients for most of these indications. We highlight the limitations associated with current liquid biopsy testing.

Conclusions And Clinical Implications: Currently, there are multiple clinical indications for liquid biopsy in routine clinical practice. These FDA-approved indications can significantly improve the outcomes for biomarker-selected patients. All providers treating patients with a genitourinary malignancy are encouraged to use these tools regularly when indicated to improve patient care. Additional applications are expected to become available for routine clinical use in the future.