# Progensa PCA3 Assay

Source: https://onco.cc/drugs/progensa-pca3/  
OnCo record `progensa-pca3` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first urine RNA test for prostate cancer approved in the United States; its approval has since been withdrawn, though Medicare still lists it.

## Summary

The FDA approved the Progensa PCA3 Assay (PMA P100033, Gen-Probe) on 13 February 2012 to measure PCA3 and PSA RNA in post-examination first-catch urine; the FDA database records a withdrawal date of 12 April 2023. Palmetto MolDX billing article A58700 still lists the Progensa PCA3 assay (CPT 81313) after a negative biopsy.

## Fields

- Kind: Test
- Status: withdrawn
- Last checked: 2026-11-04
- Also known as: PCA3 urine test; Progensa
- Tags: test; rna
- Brand: Progensa PCA3
- Modality: Urine RNA test (PCA3 and PSA RNA, after a negative biopsy)
- Mechanism: Nucleic acid amplification measures PCA3 and PSA RNA in first-catch urine collected after a digital rectal examination and reports their ratio.
- Approvals: US 2012: FDA PMA approval (P100033) of a urine PCA3 RNA test to aid the decision on repeat biopsy for prostate cancer; withdrawn 12 April 2023

## Sources

- FDA PMA P100033: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100033
- CMS article A58700: Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58700

## Connected records

- drugs: [ExoDx Prostate (IntelliScore)](https://onco.cc/drugs/exodx-prostate/)
- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Liquid RNA biopsy (cell-free, vesicle and platelet RNA)](https://onco.cc/technologies/liquid-rna-biopsy/)

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