Artera

Enhancing oncology precision with AI-driven, rapid cancer assessments.. [Contact for Pricing]

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What is Artera?

Artera is a precision medicine company that develops AI-powered predictive and prognostic cancer tests to personalize cancer therapy. The company's flagship product is the ArteraAI Prostate Test, the first and only AI test recommended in the NCCN Clinical Practice Guidelines in Oncology for Prostate Cancer. This test analyzes digital pathology images of a patient's prostate cancer biopsy slide combined with clinical data to predict 10-year risk of distant metastasis and prostate-cancer specific mortality, while also predicting which NCCN Intermediate-risk patients will benefit from short-term androgen deprivation therapy (ST-ADT) with radiation therapy.

Artera uses a unique Multi-modal Artificial Intelligence (MMAI) platform that analyzes both digital pathology images and clinical data for personalized cancer management. The company also offers the ArteraAI Breast Cancer Test, which provides 5- and 10-year distant metastasis risk for early-stage breast cancer patients and predicts which node-negative patients 50 years or older will benefit from chemotherapy. The MMAI architecture can potentially create biomarkers to guide personalized treatment decision-making across various cancer types.

The tests are designed for oncologists, urologists, radiation oncologists, and cancer patients who need help making informed treatment decisions. The ArteraAI Prostate Test is intended for adult males with localized prostate cancer, including those with NCCN Very Low-, Low-, Favorable-Intermediate, Unfavorable-Intermediate, High-, and Very High-risk disease, as well as patients with biochemical recurrence following prostatectomy. The company is based in Los Altos, California, with testing performed at a CLIA-certified laboratory in Jacksonville, Florida.

Artera's AI tests are validated in dozens of large, randomized phase III clinical trials and have received FDA De Novo marketing authorization for the Prostate Test and FDA Breakthrough Device Designation. The test does not consume tissue since it uses image data from existing H&E slides with no additional staining required, and results are typically ready within 1-2 days after specimen receipt.

Artera pricing

Pricing model: Freemium

The ArteraAI Prostate Test has a Medicare payment rate of $700 effective January 1, 2024, with zero out-of-pocket costs for Medicare Plan B patients. For patients with private insurance, financial liability is subject to their plan terms including copays, coinsurance, and deductibles. The out-of-pocket cost for privately insured patients varies based on their insurance plan. Patients can contact [email protected] for estimated out-of-pocket liability. A Financial Assistance Program is available to help reduce out-of-pocket costs. For Early Access Program participants, tests can be ordered with zero out-of-pocket costs. The test is clinically available through a CLIA-certified laboratory in Jacksonville, Florida.

Artera pros

  • First and only AI test recommended in NCCN Guidelines for Prostate Cancer
  • FDA De Novo marketing authorization granted for ArteraAI Prostate
  • FDA Breakthrough Device Designation received
  • Predicts both prognostic outcomes and therapeutic benefit
  • Does not consume tissue - uses existing H&E slides
  • No additional staining or preparation required
  • Rapid 1-2 day turnaround time after specimen receipt
  • Validated across six phase III randomized clinical trials
  • Consistent performance in African American and non-African American men
  • Fully reimbursed for Medicare patients at $700
  • Available in all 50 US states
  • Partnerships in Puerto Rico, UK, Australia, and Israel
  • Online test ordering available at artera.ai
  • Augments clinician decision-making rather than replacing it
  • Provides actionable insights for personalized treatment planning

Artera cons

  • Not available in New York and California pending regulatory approval
  • Only clinicians can order - not direct-to-patient
  • Private insurance coverage varies by plan
  • Relatively new test with limited clinical experience
  • Requires existing pathology slides from biopsy
  • Out-of-pocket costs depend on individual insurance plan
  • Limited to prostate and breast cancer currently
  • May not be covered by all commercial health plans

Frequently asked questions about Artera

What is the ArteraAI Prostate Test?

The ArteraAI Prostate Test is the first and only AI-powered risk stratification tool for prostate cancer recommended in the NCCN Clinical Practice Guidelines in Oncology. It analyzes digital pathology images of a patient's prostate cancer biopsy slide combined with clinical factors to predict 10-year risk of distant metastasis and prostate-cancer specific mortality. It also predicts which NCCN Intermediate-risk patients will benefit from short-term androgen deprivation therapy with radiation therapy.

How quickly do I get results?

ArteraAI Prostate Test results are typically ready within 1-2 days after receipt of the patient's specimen in the CLIA-certified lab in Jacksonville, Florida. This rapid turnaround helps clinicians and patients review the information together to determine the optimal treatment path forward.

Does the test require additional tissue from my biopsy?

No, the ArteraAI Prostate Test does not consume tissue. The test uses a patient's existing pathology slides and digitizes them for the AI model. No additional staining or preparation is required, which solves the problem of finite tissue available from biopsies.

Is the test covered by insurance?

Yes, the ArteraAI Prostate Test is fully reimbursed for Medicare patients at a rate of $700 with zero out-of-pocket costs for Medicare Plan B patients. Many commercial health plans also provide coverage, though out-of-pocket costs for privately insured patients depend on their specific plan terms including copays, coinsurance, and deductibles.

Who can order the ArteraAI Prostate Test?

Ordering of the ArteraAI Prostate Test is limited to clinicians whose license and scope of practice allows them to order the test. Patients cannot order the test directly and must work with their doctor. Clinicians can order the test online at artera.ai.

Is the test available for all prostate cancer patients?

The ArteraAI Prostate Test is available for adult males with localized prostate cancer across NCCN risk categories including Very Low-, Low-, Favorable-Intermediate, Unfavorable-Intermediate, High-, and Very High-risk. There is also a Post-RP version for patients with biochemical recurrence following prostatectomy who have not yet received radiation or hormone therapy.

How does Artera ensure diversity in its AI models?

Artera's MMAI models were intentionally developed using cohorts consisting of about 20% African Americans, which reflects the 16% prevalence of prostate cancer in this patient population. The models have demonstrated similar prognostic performance between African American and non-African American men, addressing the historical underrepresentation of minority populations in clinical trials.

What is the ArteraAI Breast Cancer Test?

The ArteraAI Breast Cancer Test provides 5- and 10-year distant metastasis risk for early-stage breast cancer patients. It also predicts which node-negative patients 50 years or older will benefit from chemotherapy. The test received FDA clearance in May 2026 and is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer.

Where is the test performed?

Testing is performed by ArteraAI at their CLIA-certified laboratory located at 6800 Southpoint Pkwy Suite 950, Jacksonville, Florida 32216. The ArteraAI Prostate Test can be ordered in all 50 US states, and the company has partners in Puerto Rico, United Kingdom, Australia, and Israel where versions of the test are available through partnerships.

What if I have concerns about out-of-pocket costs?

Patients should contact [email protected] for additional questions about their estimated out-of-pocket liability. Artera offers a Financial Assistance Program to help reduce potential out-of-pocket costs associated with testing. For Early Access Program participants, tests can be ordered with zero out-of-pocket costs to patients.

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