ArteraAI Prostate
The first AI tool cleared by the FDA to predict both prognosis and treatment benefit from a routine biopsy slide, in prostate cancer.
De novo authorisation August 2025. Multimodal AI on H&E biopsy images plus clinical variables predicts distant metastasis and benefit from short-term androgen deprivation with radiotherapy (validated on NRG/RTOG trial cohorts). NCCN-listed.
1.Biopsy slides are scanned to digital images
- Medicare
- Part B (clinician-administered)
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 insurance
- variable
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.
- Notes
- Not available on the NHS; NICE early value assessment route applies to digital prognostic tools.
- NHS England
- Not routinely funded
Sources: NICE search: ArteraAI Prostate. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 14 Aug 2025ApprovalUS
De novo authorisation: first AI pathology test cleared for prognostic and predictive use in localised prostate cancer source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
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