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The first AI tool cleared by the FDA to predict both prognosis and treatment benefit from a routine biopsy slide, in prostate cancer.
ArteraAI Prostate is a multimodal artificial intelligence test that combines a deep-learning image encoder applied to routine H&E biopsy slides with clinical variables to predict the risk of distant metastasis and the benefit of short-term androgen deprivation therapy added to radiotherapy in localised prostate cancer. It was validated retrospectively on NRG/RTOG randomised trial cohorts, received FDA de novo authorisation in August 2025 as the first AI tool cleared to predict both prognosis and treatment benefit from a slide, and is listed in NCCN guidelines. Its practical use is helping men with intermediate-risk disease decide whether hormone therapy is worth its side effects. Prospective validation is the open question. For a newcomer: software that reads a biopsy slide to say how aggressive the cancer is and whether hormone therapy will help.
Deep-learning image encoder plus clinical data fusion.
1.Biopsy slides are scanned to digital images
Digital pathology prognostic test covered by Medicare for localised prostate cancer through the MolDX programme (Palmetto GBA local coverage) since 2023; billed as a laboratory test under Part B with no coinsurance.
Commercial coverage is limited and case by case; the lab often bills the patient after a coverage denial or offers a financial assistance programme.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Clinical laboratory tests · CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE search: ArteraAI Prostate. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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De novo authorisation: first AI pathology test cleared for prognostic and predictive use in localised prostate cancer source
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Localised prostate cancer risk stratification and ADT benefit prediction |
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare coverage via MolDX; NCCN-listed | ~$1,500 (Medicare CLFS rate established 2025, approximate) | - |
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:"ArteraAI Prostate" OR ABSTRACT:"ArteraAI Prostate") 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 ArteraAI Prostate, not a curated reading list.
Shares Artera, AI in the oncology clinic: from narrow cleared tools to multimodal decision support, Pathology & radiology foundation models, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment.
Shares AI in the oncology clinic: from narrow cleared tools to multimodal decision support, Pathology & radiology foundation models, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, AI in oncology roadmap: pattern readers → foundation models → agents in the workflow.
Shares Artera, AI in the oncology clinic: from narrow cleared tools to multimodal decision support, Pathology & radiology foundation models, AI in oncology roadmap: pattern readers → foundation models → agents in the workflow.
Shares AI in the oncology clinic: from narrow cleared tools to multimodal decision support, Pathology & radiology foundation models, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, AI in oncology roadmap: pattern readers → foundation models → agents in the workflow.
Shares Pathology & radiology foundation models, AI in oncology roadmap: pattern readers → foundation models → agents in the workflow, Digital pathology & AI, Prostate cancer.
Shares AI in the oncology clinic: from narrow cleared tools to multimodal decision support, Pathology & radiology foundation models, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, AI in oncology roadmap: pattern readers → foundation models → agents in the workflow.
Shares Pathology & radiology foundation models, AI in oncology roadmap: pattern readers → foundation models → agents in the workflow, AI that is built but not validated or deployed, Digital pathology & AI.
Shares Localised prostate cancer, very low and low risk, Localised prostate cancer, intermediate risk, Localised prostate cancer, high and very high risk, Prostate cancer.