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The first urine RNA test for prostate cancer approved in the United States; its approval has since been withdrawn, though Medicare still lists it.
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.
Nucleic acid amplification measures PCA3 and PSA RNA in first-catch urine collected after a digital rectal examination and reports their ratio.
| Region | Year | Indication |
|---|---|---|
| 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| 2012 | FDA PMA approval (P100033) of a urine PCA3 RNA test to aid the decision on repeat biopsy for prostate cancer; withdrawn 12 April 2023 |
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Query for this drug: (TITLE:"Progensa PCA3 Assay" OR ABSTRACT:"Progensa PCA3 Assay" OR TITLE:"Progensa PCA3" OR ABSTRACT:"Progensa PCA3" OR TITLE:"PCA3 urine test" OR ABSTRACT:"PCA3 urine test" OR TITLE:"Progensa" OR ABSTRACT:"Progensa") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Progensa PCA3 Assay, not a curated reading list.
Shares ExoDx Prostate (IntelliScore), Liquid RNA biopsy (cell-free, vesicle and platelet RNA), Prostate cancer and the tags test, rna.
Shares ExoDx Prostate (IntelliScore), Liquid RNA biopsy (cell-free, vesicle and platelet RNA), Prostate cancer and the tags test, rna.
Shares ExoDx Prostate (IntelliScore), Liquid RNA biopsy (cell-free, vesicle and platelet RNA), Prostate cancer and the tags test, rna.
Shares ExoDx Prostate (IntelliScore), Liquid RNA biopsy (cell-free, vesicle and platelet RNA), Prostate cancer.
Shares Liquid RNA biopsy (cell-free, vesicle and platelet RNA) and the tags test, rna.
Shares the tags test, rna.
Shares the tags test, rna.
Shares the tags test, rna.
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