ArteraAI Prostate

by Artera  · Based in United States → — AI-Enabled Cancer Therapy Personalization
Oncology Pathology Urology
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The out-of-pocket cost for the arteraai prostate test is based on the patient's insurance plan. for patients covered by medicare plan b, there are typically zero out-of-pocket costs. for those with private insurance, financial liability is subject to their plan's terms, including copays, coinsurance, and deductibles. artera offers a financial assistance program for commercially insured patients with high out-of-pocket costs.
Regulatory Status Disclosed

Overview

The ArteraAI Prostate Test is an advanced AI-powered diagnostic tool designed to personalize prostate cancer therapy. It leverages a multimodal artificial intelligence (MMAI) platform that analyzes digital images from a patient’s biopsy and integrates it with their clinical data. This comprehensive analysis provides both prognostic and predictive insights for patients with localized prostate cancer, empowering clinicians to make more informed treatment decisions. The test can predict therapy benefit, such as the efficacy of hormone therapy, and prognosticate long-term outcomes, including the 10-year risk of distant metastasis, biochemical failure, prostate cancer-specific survival, and overall survival.

The ArteraAI Prostate Test is recommended in the NCCN Clinical Practice Guidelines in Oncology and has received De Novo authorization from the FDA, recognizing it as the first and only AI-powered tool authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. It operates as an FDA-regulated Software as a Medical Device (SaMD) and is clinically available through a CLIA-certified laboratory.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered prognostic and predictive insights for localized prostate cancer
  • Analyzes digital pathology images from biopsy and clinical data
  • Predicts therapy benefit, including hormone therapy
  • Prognosticates long-term outcomes (distant metastasis, biochemical failure, prostate cancer-specific survival, overall survival)
  • Recommended in NCCN Clinical Practice Guidelines in Oncology
  • Utilizes existing H&E slides without consuming tissue
  • Provides rapid turnaround time (1-2 days after specimen receipt)
  • Demonstrates consistent prognostic performance across diverse populations
  • Supports active surveillance decision-making for lower-risk patients
  • Applicable for localized prostate cancer and recurrent prostate cancer after radical prostatectomy (Post-RP)

Use Cases

  • Personalizing prostate cancer treatment decisions
  • Guiding active surveillance for lower-risk prostate cancer patients
  • Predicting benefit from hormone therapy (e.g., ST-ADT) with radiation therapy
  • Assessing long-term outcomes for localized prostate cancer
  • Informing treatment decisions for recurrent prostate cancer after radical prostatectomy
  • Reducing overtreatment and improving quality of life for cancer patients

What Physicians Need to Know

Key Capabilities
ArteraAI Prostate is a multimodal artificial intelligence (MMAI) biomarker test that analyzes digital images from patient biopsies and clinical data. It provides both prognostic insights into long-term outcomes (e.g., 10-year risk of distant metastasis, prostate cancer-specific mortality, biochemical failure, overall survival) and predictive insights into therapy benefit (e.g., short-term hormone therapy, abiraterone). The test is available for localized prostate cancer and recurrent prostate cancer after radical prostatectomy, and it does not consume tissue.
Clinical Utility
The tool personalizes treatment decisions for localized prostate cancer, helping identify patients who may benefit from specific therapies like short-term hormone therapy or abiraterone, potentially sparing others from unnecessary toxicities. It also supports active surveillance decision-making across NCCN risk groups and has demonstrated superior performance compared to standard risk models in prognosticating outcomes. Results are typically available within 1-2 days, aiding timely clinical decisions.
Integration Options
ArteraAI Prostate integrates seamlessly into standard pathology workflows, requiring digitized images of patient biopsy slides and clinical information. Clinicians can access patient reports via an online portal or fax. The platform leverages AWS Cloud services for its web portal and AI/ML inference, and it is compatible with FDA-cleared interoperable scanners or 510(k)-cleared scanners assessed via a Predetermined Change Control Plan.
Compliance Status
The ArteraAI Prostate Test is a Laboratory Developed Test (LDT) offered through a CLIA-certified laboratory. The ArteraAI Prostate (medical device version) received FDA Breakthrough Device Designation and subsequently FDA De Novo authorization, classifying it as a Class II Software as a Medical Device (SaMD) for prognosticating long-term outcomes in localized prostate cancer. It is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelinesu00ae) for Prostate Cancer with Level IB evidence and a Category 2A recommendation. ArteraAI is also SOC 2 Type II certified and HIPAA compliant.
Pricing Model
The out-of-pocket cost for the ArteraAI Prostate Test depends on the patient's insurance plan. It is fully reimbursed for Medicare Plan B patients (zero out-of-pocket costs). For private insurance, financial liability is subject to plan terms, including copays, coinsurance, and deductibles. The Centers for Medicare & Medicaid Services (CMS) established a payment rate effective January 1, 2024. A financial assistance program is available for qualifying patients.
User Experience
The test reports are designed to be clear, straightforward, and easy to interpret, facilitating confident treatment decisions. The process is convenient and easily incorporated into existing clinical workflows, with rapid results (1-2 days) significantly reducing patient waiting times. The tool is intended to augment clinician work and empower shared decision-making between physicians and patients.
Support Quality
ArteraAI provides a Customer Success Team to assist with account activation. Support for ordering and general inquiries is available via email ([email protected]), and billing questions can be directed to [email protected] or a dedicated phone number. The company maintains rigorous quality assurance, including pathologist review of slides, multidisciplinary case reviews, and adherence to defined protocols by lab directors and technicians.
Implementation Complexity
Implementation is designed to be seamless within standard pathology workflows, primarily requiring digitized biopsy images and clinical data. Artera's CLIA-certified lab performs the analysis, eliminating the need for additional tissue preparation or staining from the clinician. Initial setup involves account activation, and the FDA De Novo authorization streamlines future expansions for compatible scanners.
Evidence Base
The ArteraAI Prostate Test was developed and validated using data from multiple large-scale, randomized Phase 3 clinical trials with up to 15-year follow-up, including diverse patient populations (e.g., ~20% African American men). It has demonstrated superior performance over standard risk models and its findings are published in reputable journals like *Nature* and *NEJM Evidence*. The test's inclusion in NCCN Guidelines with Level IB evidence and a Category 2A recommendation further underscores its robust clinical validation.
Physician Tip

Consider ArteraAI Prostate for patients with localized prostate cancer to gain personalized prognostic and predictive insights, especially when evaluating the benefit of short-term hormone therapy or abiraterone, or when informing active surveillance decisions. The rapid turnaround time can significantly aid in timely treatment planning. Leverage the clear reports to facilitate shared decision-making with patients, enhancing confidence in chosen treatment pathways. Be aware of the test's strong evidence base, including NCCN guideline inclusion and FDA authorization, to support its integration into clinical practice.

ArteraAI Prostate is designed to integrate into existing pathology workflows by utilizing digitized biopsy images and clinical data. While direct EHR integration details are not extensively specified, the use of an online clinician portal and fax options suggests standard methods for result delivery. Its cloud-based architecture (AWS) indicates a scalable and secure backend. Compatibility with specific digital pathology scanners is a key consideration for seamless implementation within a pathology lab's infrastructure.

Details

Category Oncology AI, Pathology AI
Pricing The out-of-pocket cost for the arteraai prostate test is based on the patient's insurance plan. for patients covered by medicare plan b, there are typically zero out-of-pocket costs. for those with private insurance, financial liability is subject to their plan's terms, including copays, coinsurance, and deductibles. artera offers a financial assistance program for commercially insured patients with high out-of-pocket costs.
  • Medicare Plan B: $0 out-of-pocket; Commercial Insurance: Varies by plan, financial assistance available; Costs expected to exceed $285 will be discussed with patient
DeploymentThe ArteraAI Prostate Test is clinically available through a single CLIA-certified laboratory in Jacksonville, FL. As an FDA-regulated Software as a Medical Device (SaMD), it enables point-of-diagnosis integration in qualified pathology laboratories.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

ArteraAI Prostate received De Novo authorization from the FDA, establishing it as the first and only AI-powered tool authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. It is recognized as an FDA-regulated Software as a Medical Device (SaMD).
Integrations
EHR Not specified
Specialties Oncology, Pathology, Urology

What the Web Says

ArteraAI Prostate is an AI-powered test that analyzes digital pathology images from a patient's prostate biopsy and clinical data to predict the likelihood of cancer metastasis and mortality, and to assess the benefit of hormone therapy (ADT). It aims to personalize treatment guidance, especially for men with intermediate-risk prostate cancer, and is included in National Comprehensive Cancer Network guidelines. While generally viewed positively for its potential to refine treatment decisions, some physicians and patients express reservations about relying solely on AI for such critical choices, particularly when results conflict with other established tests or guidelines.

Overall: Mixed

Strengths

  • Provides personalized predictions for metastasis and mortality risk.
  • Predicts whether hormone therapy (ADT) will actually benefit the patient, potentially helping to avoid unnecessary side effects.
  • Uses existing biopsy samples and clinical data, requiring no new procedures.
  • Results are typically available quickly (1-2 days).
  • Can help in decision-making for active surveillance, radiation therapy, and post-prostatectomy salvage therapy.
  • Covered by Medicare and some private insurance.

Limitations

  • Some physicians and patients are hesitant to fully trust AI for critical treatment decisions, especially when it contradicts established guidelines or other tests.
  • May not be available in all states (e.g., California and New York).
  • The dataset used for training, while in the thousands, has been questioned by some as potentially small for comprehensive accuracy.
  • Can produce discordant results when compared to other biomarker tests like Decipher, leading to confusion for patients and doctors.
  • Some oncologists and radiologists may still recommend ADT despite a negative ArteraAI biomarker, citing other studies or clinical experience.
  • Currently, it may not incorporate all relevant information like PET scans and MRI findings into its machine learning model.

Based on reviews from: Reddit (r/ProstateCancer), Mayo Clinic Connect, YouTube (The Prostate Cancer Research Institute - PCRI), Imaging Technology News, The Cancer Letter, HealthUnlocked (Prostate Cancer Network), G2, PCa Commentary

Last updated: 2026-07-20

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Press & Coverage

Cancer Network
ArteraAI Pathology Test Launches for Personalizing Prostate Cancer Therapy
The ArteraAI Prostate Test, an AI-powered digital pathology solution, has launched to help urologists and oncologists personalize therapy intensity for patients with metastatic hormone-sensitive prostate cancer (HSPC). This platform is the first externally developed prostate digital pathology algorithm embedded for clinical use within the Tempus diagnostics ecosystem.
2026-05
ArteraAI (Press Release)
Artera Receives U.S. FDA De Novo Marketing Authorization for AI-Digital Pathology Software Revolutionizing Prostate Cancer Care
Artera announced that the U.S. FDA granted De Novo authorization for ArteraAI Prostate, making it the first and only AI-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. This authorization establishes ArteraAI Prostate as an FDA-regulated Software as a Medical Device (SaMD).
2025-08
Imaging Technology News
FDA Grants Breakthrough Device Designation for Artera's AI-Powered Software for Prostate Cancer Care | Imaging Technology News
The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to ArteraAI Prostate, an AI precision medicine tool to assist clinicians with risk-based decisions for patients with localized prostate cancer. This designation may expedite the FDA authorization process for the software.
2025-07
Urology Times
FDA grants De Novo authorization for first AI-powered prostate cancer prognostic tool
The FDA granted De Novo authorization to ArteraAI Prostate, making it the first and only AI-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. This decision establishes ArteraAI Prostate as a regulated Software as a Medical Device and creates a new product code category for future AI-powered digital pathology risk-stratification tools.
2025-08
Labcompare
Artera Receives CE Marks for AI-Powered Prostate and Breast Cancer Tests
Artera has received CE marking under the European Union In Vitro Diagnostic Regulation for its ArteraAI Prostate Biopsy Assay and ArteraAI Breast Cancer Assay, allowing for their clinical use across the EU and other territories. The ArteraAI Prostate Biopsy Assay is the first CE-marked AI-enabled prognostic and predictive in vitro diagnostic test for prostate cancer in the EU.
2026-05
ArteraAI (Press Release)
Artera Debuts ArteraAI Prostate Test (Postu2011RP), Expanding its Oncology Portfolio
Artera commercially launched the ArteraAI Prostate Test (Post-RP) for patients experiencing biochemical recurrence (BCR) following radical prostatectomy. This new AI-driven test provides prognostic results and insights into short-term ADT benefit to optimize decision-making in the salvage therapy setting.
2025-12
JNCI Cancer Spectrum (Oxford Academic)
Cost-effectiveness of an artificial intelligence predictive model for guiding androgen deprivation therapy in intermediate-risk prostate cancer
This study evaluated the cost-effectiveness of the ArteraAI Prostate Test in guiding short-term androgen deprivation therapy (ADT) for intermediate-risk prostate cancer patients receiving radiotherapy. The analysis concluded that using the ArteraAI Test was the dominant strategy compared to other approaches.
2026-04
Tempus AI, Inc. (Press Release)
Tempus Launches ArteraAI Prostate Test for Metastatic Patients, Marking the First Prostate Digital Pathology Algorithm in the Tempus Ecosystem Available for Clinical Use
Tempus AI announced the clinical launch of the ArteraAI Prostate Test (mHSPC), a CLIA-certified and CAP-accredited prognostic test for metastatic hormone-sensitive prostate cancer. This test is fully integrated into the Tempus platform, providing a digital pathology solution for personalized therapy.
2026-05

Videos

Product demos, reviews, and walkthroughs for ArteraAI Prostate.

View all on YouTube

Frequently Asked Questions

ArteraAI Prostate analyzes digital pathology images from a patient's biopsy alongside their clinical data to provide prognostic and predictive insights. It aids in decision-making for active surveillance, predicts the benefit from therapies like short-term hormone therapy, and can help identify patients who may benefit from abiraterone. The test results are typically available within 1-2 days, augmenting the clinician's ability to personalize treatment plans.
ArteraAI Prostate has received De Novo authorization from the FDA, making it the first AI-powered tool authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer, following an earlier Breakthrough Device Designation. The company is committed to data privacy, being HIPAA compliant and SOC 2 Type II certified, with sensitive data hosted on secure, encrypted cloud services.
The test prognosticates long-term outcomes such as 10-year risk of distant metastasis and prostate cancer-specific mortality. It also predicts therapy benefit, identifying patients who may benefit from short-term hormone therapy or the addition of abiraterone to standard treatment. ArteraAI Prostate has been validated across multiple Phase 3 randomized trials and diverse patient populations, demonstrating superior performance compared to standard risk models.
While other genomic tests like Decipher or Prolaris exist for prostate cancer risk assessment, ArteraAI Prostate is distinct in its use of multimodal AI to analyze digital pathology images and clinical data without consuming additional tissue. Other AI solutions in prostate pathology, such as those from Aira Matrix, Deep Bio, Ibex Medical Analytics, and Mindpeak, primarily focus on automating cancer detection and grading from images. ArteraAI's unique offering includes both prognostic and predictive insights for long-term outcomes and specific therapy benefits.
The ArteraAI Prostate Test is fully reimbursed under Medicare's established payment rate, meaning no out-of-pocket costs for covered Medicare Part B patients. Many commercial insurers and health plans are also beginning to cover the test, though coverage details vary by plan. ArteraAI offers a financial assistance program to help reduce potential out-of-pocket costs for eligible patients.
While rigorously validated, analytical studies indicate some variability in results based on the number of biopsy cores on a slide, though overall reliability remains high. Crucially, ArteraAI has conducted large-scale comparative analyses demonstrating no evidence of algorithmic bias across racially diverse patient populations, addressing concerns about equitable performance in prostate cancer care.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed ArteraAI Prostate

Funded through the company that built this tool.

Unorthodox Ventures
VC T3
Austin, United States
$1M-$5M
Unorthodox Ventures is a US-based investment platform at unorthodoxventures.com with a Crunchbase and LinkedIn presence, positioned as a non-traditional capital partner that…
Diagnostics Medical Devices / MedTech
Martin Ventures
Family Office T3
Nashville, United States
$1M-$5M
Martin Ventures is the personal investment vehicle of healthcare entrepreneur Tom Martin, with a sustained track record of backing healthcare services and…
AI/ML in Healthcare Care Delivery / Tech-Enabled Services
Exceptional Ventures
VC T3
London, United Kingdom
$250k-$1M
Exceptional Ventures is a UK-based early-stage venture firm with a stated thesis around human flourishing, longevity, mental health, women’s health, and the…
AI/ML in Healthcare Biotech
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