Public source

Reviewed 29 Jul 2026

Completeness Good (44%)

ArteraAI Prostate Biopsy Assay

ArteraAI

The ArteraAI Prostate Test can be used for patients across all NCCN risk groups, with 10-year risk of distant metastasis (DM) and prostate cancer-specific mortality (PCSM) reported and can be used to assess how aggressive the cancer is.

For lower-risk patients, the ArteraAI Prostate Test provides a binary indication of distant metastasis risk, indicating if the patient’s risk may warrant earlier treatment.

For intermediate-risk patients, the ArteraAI Prostate Test can be used to predict if there will be a therapeutic benefit from adding ST-ADT to radiation therapy.

For higher-risk patients, the ArteraAI Prostate Test can help inform if adding abiraterone to LT-ADT and radiation therapy may be of benefit.

Supported by 10 papers

General Information

Product name

ArteraAI Prostate Biopsy Assay

Company

Modality

Histopathology

Main task

Prognosis (Risk stratification)

Subspeciality

Uropathology

Organ/Specimen source

Not specified

Disease targeted

Prostate cancer

Specimen type

Biopsy

Staining

H&E

Stain subtype

Not specified

Regulatory Information

FDA Certification

Pathway:

De novo 510(k) cleared

Class:

Class II

FDA Number:

Verified by Health AI Register

CE-IVD Certification

Pathway:

In Vitro Diagnostic Regulation (IVDR)

Class:

Class C

Not verified by Health AI Register

Scanner Brands Certified for Use (CE-IVD)

Not specified

Scanner Models Certified for Use (CE-IVD)

Not specified

Other certifications

Not specified

Evidence & Research

Peer-Reviewed Papers

Cost-effectiveness of an artificial intelligence predictive model for guiding androgen deprivation therapy in intermediate-risk prostate cancer

JNCI Cancer Spectrum · Apr 2026

External validation of a digital pathology-based multimodal artificial intelligence-derived prognostic model in patients with advanced prostate cancer starting long-term androgen deprivation therapy: a post-hoc ancillary biomarker study of four phase 3 randomised controlled trials of the STAMPEDE platform protocol

The Lancet Digital Health · Jun 2025

Assessing Algorithmic Fairness With a Multimodal Artificial Intelligence Model in Men of African and Non-African Origin on NRG Oncology Prostate Cancer Phase III Trials

JCO Clinical Cancer Informatics · May 2025

Validation of a Digital Pathology–Based Multimodal Artificial Intelligence Biomarker in a Prospective, Real-World Prostate Cancer Cohort Treated with Prostatectomy

Clinical Cancer Research · Feb 2025

An Artificial Intelligence–Digital Pathology Algorithm Predicts Survival After Radical Prostatectomy From the Prostate, Lung, Colorectal, and Ovarian Cancer Trial

Journal of Urology · Feb 2025

Digital Pathology–Based Multimodal Artificial Intelligence Scores and Outcomes in a Randomized Phase III Trial in Men With Nonmetastatic Castration-Resistant Prostate Cancer

JCO Precision Oncology · Jan 2025

Digital Pathology–based Artificial Intelligence Biomarker Validation in Metastatic Prostate Cancer

European Urology Oncology · Dec 2024

Validation of an artificial intelligence-based prognostic biomarker in patients with oligometastatic Castration-Sensitive prostate cancer

Radiotherapy and Oncology · Nov 2024

Prostate Cancer Risk Stratification in NRG Oncology Phase III Randomized Trials Using Multimodal Deep Learning With Digital Histopathology

JCO Precision Oncology · Oct 2024

External Validation of a Digital Pathology-based Multimodal Artificial Intelligence Architecture in the NRG/RTOG 9902 Phase 3 Trial

European Urology Oncology · Feb 2024

Technical Specifications

Patient population age

Not specified

Input

Not specified

Input format

Not specified

Output

Not specified

Output format

Not specified

Integration

Not specified

Deployment

External service

Trigger for analysis

Not specified

Processing time

Not specified

Population

The ArteraAI Prostate Test (Biopsy) is intended for adult males 18 years of age or older with localized prostate cancer, without clinically or pathologically defined metastases. The intended patient should also be a candidate for curative intent management (surgery, radiation therapy ± systemic therapy, or active surveillance).

Viewer systems

Not specified

Market Presence

On market since

Not specified

AI Platforms

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Pay-per-use

Based on

Not specified

Source: Public | First published: Apr 21, 2026 | Last updated: Jul 29, 2026