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Commercially Available Laboratory Developed Test

The ArteraAI Prostate Test is the first AI risk stratification tool recommended for patients with localized prostate cancer in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate CancerReferenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024. ©National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 4, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
NCCN, National Comprehensive Cancer Network.
. The test is intended to help clinicians and patients make personalized treatment decisions with more confidence.

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View a Sample Test Report

Explore the ArteraAI Prostate Test report and how it can help personalize prostate cancer treatment.

The science behind the ArteraAI Prostate Test

Artera’s multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses both the digital images from a patient’s biopsy and their clinical data. The AI combines this information to estimate long-term outcomes and predict whether a patient will benefit from hormone therapy.

Results can be shared within 2-3 days after receipt of the patient’s specimen. The algorithm was developed using large datasets, from thousands of patients and tens of thousands of pathology slide images, and has been clinically validated using multiple Phase 3 randomized trials.

Suitable for patients across all risk groups

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 patientsFor patients with NCCN very low-, low-, or favorable intermediate-risk disease., the ArteraAI Prostate Test will also report the relative risk of adverse pathology (AP) at radical prostatectomy (RP) to help inform if active surveillance is a suitable management option.

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.

 

Risk Group Chart

Predicting therapeutic benefit from hormone therapy

It is the first AI-enabled test to be included in the NCCN Guidelines® for Prostate Cancer, and the only test recommended for its predictive performance regarding the use of short-term ADT.Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024. ©National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 4, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. Spratt DE, et al. NEJM Evidence. 2023;2(8):EVIDoa2300023. NCCN, National Comprehensive Cancer Network.

Current method

Men with intermediate localized prostate cancer are often treated with short-term androgen-deprivation therapy in combination with radiation therapy (RT + ST-ADT), but only ~⅓ of men actually benefit from it. This needlessly exposes them to the side effects of medical castration such as sexual dysfunction, cognitive impairment, and metabolic impairment.

Overall Analysis Population (RTOG 9408)

Shows marginal benefit to including short-term hormone therapy in combination with radiation therapy.

Hazard ratio: 0.64 (95% CI, 0.45-0.90, P = 0.01)
n = 1719 patients studied

With ArteraAI Prostate Test

The AI identifies the 1/3 of patients who may greatly benefit from short-term hormone therapy.Source: https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300023

AI Biomarker Negative

Identify patients who are less likely to benefit from short-term hormone therapy.

Hazard ratio: 0.92 (95% CI, 0.59-1.43, P = 0.71)
n = 1046 patients studied

Interaction p-value = 0.002

AI Biomarker Positive

Identify patients who may greatly benefit from short-term
hormone therapy.

Hazard ratio: 0.34 (95% CI, 0.19-0.63, P < 0.001)
n = 673 patients studied

Interaction p-value = 0.002

Outperforming standard clinical tools

Multimodal AI (ArteraAI Prostate Test) is also the first AI-enabled prognostic test recommended in the NCCN Guidelines for Prostate Cancer.Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024. ©National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 4, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. Esteva A, et al. Nature Digital Medicine. 2022;5(1):71. NCCN, National Comprehensive Cancer Network.

The test uses AI models to estimate long-term, clinically relevant outcomesSource: https://pubmed.ncbi.nlm.nih.gov/35676445/ for:

  • Distant metastasis (DM)
  • Biochemical failure (BF)
  • Prostate cancer-specific survival (PCSS)
  • Overall survival (OS)

Distant metastasis (DM)

Refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.

(p <0.001*)
(p <0.001*)

Biochemical failure (BF)

Defined as any increase of at least 2 ng/mL from the lowest PSA reading.

(p <0.001*)
(p <0.004*)

Prostate cancer-specific survival (PCSS)

Defined from the time of recurrence until death from disease.

(p <0.001*)

Overall survival (OS)

A way to measure how well a new treatment works by reviewing a patient’s lifespan. This can begin at the date of diagnosis or start of treatment.

(p <0.001*)

Hear from Leading Medical Experts

I think that this test is really transformative. We have never had any predictive biomarkers to use in clinical practice until now. We have been talking about this and wanting a tool like this for decades.

Daniel E. Spratt, MD
University Hospitals Seidman Cancer Center

Advanced AI tools for prostate cancer risk stratification, such as the ArteraAI Prostate Test, are now transforming how we counsel our patients regarding treatment and outcomes.

Zachary Klaassen, MD
Georgia Cancer Center

It's really amazing to be involved in this type of AI work in collaboration with Artera. The ability to use digital pathology to understand disease risk is really incredible. It opens up doors not just to prognosis, but also prediction and maybe understanding molecular aspects that go beyond what we can see.

Todd Morgan, MD
Michigan Medicine

ArteraAI benefits both clinicians and patients

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Insights for all patient cohorts

ArteraAI Prostate Test is the first test that can predict therapy benefit, help inform active surveillance decision-making, and prognosticate long-term outcomes in localized prostate cancer.

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Robust model validation

Multiple Phase 3 randomized trials with up to 15-year follow-up were used to develop and validate prognostic and predictive AI models. The prognostic model has also been validated across patients regardless of subsequent management options.Validation cohorts included patients who were managed with active surveillance, were treated with radiation therapy, or had a radical prostatectomy.

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Representing diverse populations

African American men are disproportionately affected, making up 16.3% of prostate cancer patients. Artera’s models were developed using clinical trial data comprising approximately 20% African American men.Roach et al. 2022. Prostate cancer risk in African American men evaluated via digital histopathology multi-modal deep learning models developed on NRG Oncology phase III clinical trials. Journal of Clinical Oncology 40, no. 16_suppl (June 01, 2022) 108-108.
https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.108

Ordering is easy with ArteraAI

The ArteraAI Prostate Test is a laboratory-developed testTesting is performed by ArteraAI, located at 6800 Southpoint Pkwy Suite 950, Jacksonville, Florida 32216. The ArteraAI Prostate Test was developed and its performance characteristics were determined by ArteraAI. This Laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) as qualified to perform high-complexity clinical laboratory testing. This test is used for clinical purposes and should not be regarded as investigational or for research. This test has not been cleared or approved by the U.S. Food and Drug Administration. that is now clinically available through a single CLIA-certified laboratory in Jacksonville, FL.

The ArteraAI Prostate Test is intended to help clinicians determine the therapeutic benefit for patients who have been diagnosed with localized prostate cancer who have not yet received androgen deprivation therapy.

Yes! You can visit the ArteraAI Test Report page to explore each section of the report to better understand the results.

Currently, Artera cannot accept orders from New York. Artera is actively pursuing New York licensing and will provide future updates to its certification status.

After you reach out to us, a member of our Customer Success team will set up an account in the ArteraAI Portal to enable order submission.

No. Ordering of the ArteraAI Prostate Test is limited to clinicians whose license and scope of practice allows them to order the test. However, we encourage patients to share information about ArteraAI with their doctor.

Using the ArteraAI Prostate Test, results can be shared within 2-3 days after receipt of the patient’s specimen.

The out-of-pocket cost for the ArteraAI Prostate Test will be based on the patient’s insurance plan. If the patient is covered by Medicare Plan B, they should have zero out-of-pocket costs for the ArteraAI Prostate Test. If the patient is covered by private insurance, financial liability will be subject to the terms of their plan taking into consideration copays, coinsurance and deductibles. Patients should contact billing@artera.ai for additional questions about their estimated out-of-pocket liability for the test.

The collaborators who help make our work possible

Explore Artera resources

ArteraAI Prostate Test Guide 2024

This test is for patients who have been diagnosed with localized prostate cancer who have not yet received radiation therapy.

Artificial Intelligence in Prostate Cancer: Predicting Who ADT Can Benefit

Artera has developed multimodal AI (MMAI)-enabled predictive and prognostic biomarkers for patients with prostate cancer using large datasets from thousands of patients enrolled in Phase 3 randomized clinical trials.

ArteraAI Prostate Test Report

This example demonstrates the details covered in a prostate report.

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