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A urine test that reads three genes from tiny vesicles shed by the prostate to estimate the chance of a significant prostate cancer, to help decide whether a biopsy is needed.
Medicare's code 0005U describes it as a "GENE EXPRESSION PROFILE BY REAL-TIME RT-PCR OF 3 GENES (ERG, PCA3, AND SPDEF), URINE, ALGORITHM REPORTED AS RISK SCORE". MDxHealth bought the ExoDx business from Bio-Techne on 15 September 2025 and now sells it as Exo mdx, stating that it was clinically proven in men aged 50 or over with PSA of 2 to 10 ng/mL considering an initial or repeat biopsy, and a "91.3% Negative predictive value for clinically significant prostate cancer at the 15.6 cut point" (the maker's figure). In its independent validation in 519 patients the urine assay plus standard of care had an area under the curve of 0.73 against 0.63 for standard of care alone, and 138 of 519 biopsies (27 per cent) would have been avoided (McKiernan 2016). Palmetto MolDX billing article A58700, under policy L38985, lists it for both the pre-biopsy and post-biopsy settings.
RNA from vesicles in a urine sample, taken without a rectal examination, is measured by real-time RT-PCR for ERG, PCA3 and SPDEF and combined into a risk score.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare (Palmetto MolDX policy L38985, billing article A58700) lists the ExoDx Prostate assay for men at increased risk of prostate cancer, before a first biopsy and after a negative one | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"ExoDx Prostate" OR ABSTRACT:"ExoDx Prostate" OR TITLE:"IntelliScore" OR ABSTRACT:"IntelliScore" OR TITLE:"Exo mdx" OR ABSTRACT:"Exo mdx" OR TITLE:"EPI" OR ABSTRACT:"EPI" OR TITLE:"ExoDx Prostate IntelliScore" OR ABSTRACT:"ExoDx Prostate IntelliScore") 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 ExoDx Prostate (IntelliScore), not a curated reading list.
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.
Shares the tags test, rna.
Shares the tags test, rna.
Shares the tags test, rna.
Shares the tags test, rna.
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