{"entity":{"id":"exodx-prostate","kind":"drug","name":"ExoDx Prostate (IntelliScore)","aka":["ExoDx Prostate","EPI","ExoDx Prostate IntelliScore","Exo mdx"],"tldr":"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.","summary":"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.","status":"established","asOf":"2026-11-04","links":[{"label":"MDxHealth: Exo mdx for physicians","url":"https://mdxhealth.com/exo-mdx-for-physicians/"},{"label":"MDxHealth: closing of the ExoDx acquisition (15 September 2025)","url":"https://mdxhealth.com/press_release/mdxhealth-announces-closing-of-exosome-diagnostics-acquisition-from-bio-techne-2/"},{"label":"CMS LCD L38985: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38985"},{"label":"CMS article A58700: Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer","url":"https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58700"}],"tags":["test","rna"],"related":["selectmdx","myprostatescore-2","progensa-pca3"],"cancers":["prostate"],"sections":[],"technologies":["liquid-rna-biopsy","prostate-screening-psa-mri"],"targets":[],"drugs":[],"companies":["mdxhealth"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-mckiernan-urine-exosome-prostate-jama-oncol-2016"],"journals":[],"dependsOn":[],"notes":[],"brand":"Exo mdx","modality":"Urine extracellular vesicle RNA test (3 genes, prostate biopsy decision)","mechanism":"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","reimbursement":"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","source":"https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58700","asOf":"2026-11-04"}],"regulatoryEvents":[]},"route":"/drugs/exodx-prostate/","neighbours":{"drug":[{"id":"mir-sentinel","kind":"drug","name":"miR Sentinel","route":"/drugs/mir-sentinel/"},{"id":"myprostatescore-2","kind":"drug","name":"MyProstateScore 2.0","route":"/drugs/myprostatescore-2/"},{"id":"progensa-pca3","kind":"drug","name":"Progensa PCA3 Assay","route":"/drugs/progensa-pca3/"},{"id":"selectmdx","kind":"drug","name":"SelectMDx","route":"/drugs/selectmdx/"}],"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"liquid-rna-biopsy","kind":"technology","name":"Liquid RNA biopsy (cell-free, vesicle and platelet RNA)","route":"/technologies/liquid-rna-biopsy/"},{"id":"prostate-screening-psa-mri","kind":"technology","name":"PSA and MRI-first prostate cancer screening","route":"/technologies/prostate-screening-psa-mri/"}],"company":[{"id":"mdxhealth","kind":"company","name":"MDxHealth","route":"/companies/mdxhealth/"}],"paper":[{"id":"paper-mckiernan-urine-exosome-prostate-jama-oncol-2016","kind":"paper","name":"A Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer at Initial Biopsy","route":"/key-papers/paper-mckiernan-urine-exosome-prostate-jama-oncol-2016/"}]}}