ArteraAI Prostate Test included in NCCN guidelines

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Prostate Cancer have included the ArteraAI test, making it the first AI-enabled predictive and prognostic test to be recommended for localized prostate cancer, the company announced in a news release.¹

Data synthesized with the recommendation highlight the test’s use in patients classified as having NCCN low-, intermediate-, or high-risk disease.

“This recognition by the NCCN Guidelines underscores the importance of incorporating innovative tools like the ArteraAI Prostate Test into clinical practice, enabling clinicians and patients to make more informed decisions and personalize treatment strategies,” said ArteraAI Chief Medical Officer Tim Showalter, MD, MPH, in the news release.¹

ArteraAI is the developer of a multimodal artificial intelligence-based test that combines patient’s digital images on biopsy and their clinical data to predict prostate cancer therapy benefit and prognosticate long-term outcomes.In the NCCN guidelines, the biomarker test has been classified as having a Level IB evidence rating per Simon Criteria. Additionally, the test is included as a Category 2A recommendation, signifying a uniform NCCN consensus on the usefulness of the tool as an option in prostate cancer.

“ArteraAI’s inclusion within the guidelines reflects its growing significance in guiding optimal patient care pathways and represents a positive step forward in improving outcomes for individuals battling prostate cancer," said Felix Y. Feng, MD, in the news release.¹ Feng is the co-founder of ArteraAI and a professor of radiation oncology, urology, and medicine at the University of California, San Francisco.

Data synthesized with the recommendation highlight the test’s use in patients classified as having NCCN low-, intermediate-, or high-risk disease.²

For patients with continuous scores, the guidelines highlight post-hoc data from 5 phase 3 trials (NRG/RTOG 9202,9408, 9413, 9910, and 0126), which demonstrated the superiority of the test for biochemical recurrence, distant metastasis (DM), prostate cancer-specific mortality, and overall survival compared with NCCN risk groups.³ The 5-year DM area under the curve was 0.83 for ArteraAI, compared with 0.72 for NCCN risk group (P < .001).

For patients classified as NCCN intermediate-risk, those with biomarker-positive disease, and those with an unfavorable prognostic risk, the guidelines recommend the addition of short-term androgen deprivation therapy (ST-ADT) to radiotherapy vs radiotherapy alone. Data highlighted in the guidelines showed that ST-ADT reduced the risk of DM compared with radiotherapy alone (sHR, 0.34; 95% CI, 0.19–0.63; P < .001) in patients who were biomarker-positive. No significant difference between treatment arms was observed between those who were biomarker-negative (sHR, 0.92; 95% CI, 0.59–1.43; P = .71).⁴

The inclusion of the test in the NCCN guidelines follows news earlier this year announcing coverage of the ArteraAI prostate cancer test by the Centers for Medicare & Medicaid Services.⁵ The established payment rate became effective on January 1, 2024.

Further, ArteraAI recently secured $20 million in capital funding to support the international expansion and commercial growth of the company and the test.⁶

Andre Esteva, CEO and co-founder of ArteraAI, concluded in the news release on the NCCN guideline inclusion, “This significant milestone not only celebrates ArteraAI's success but also paves the way for the integration of AI-enabled solutions into clinical practice, illustrating their potential to enhance personalized patient care.”¹

References

1. ArteraAI announced as the first-and-only predictive test for therapy personalization in the 2024 NCCN Guidelines for prostate cancer. News release. ArteraAI. March 4, 2024. Accessed March 5, 2024. https://www.businesswire.com/news/home/20240304893588/en/ArteraAI-Announced-as-the-First-and-Only-Predictive-Test-for-Therapy-Personalization-in-the-2024-NCCN-Guidelines%C2%AE-for-Prostate-Cancer

2. NCCN guidelines: prostate cancer. https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1459

3. Esteva A, Feng J, van der Wal D, et al. Prostate cancer therapy personalization via multi-modal deep learning on randomized phase III clinical trials. NPJ Digit Med. 2022;5(1):71. doi:10.1038/s41746-022-00613-w

4. Spratt DE, Tang S, Huang HC, et al. Artificial Intelligence predictive model for hormone therapy use in prostate cancer. Res Sq. 2023:rs.3.rs-2790858. doi:10.21203/rs.3.rs-2790858/v1

5. ArteraAI receives Medicare payment rate for the ArteraAI prostate cancer test. News release. January 3, 2024. Accessed March 5, 2024. https://www.businesswire.com/news/home/20240103190751/en/ArteraAI-Receives-Medicare-Payment-Rate-for-the-ArteraAI-Prostate-Cancer-Test

6. ArteraAI secures $20 million in funding to further personalize cancer therapy with multimodal AI. News release. February 1, 2024. Accessed March 5, 2024. https://www.businesswire.com/news/home/20240201133920/en/ArteraAI-Secures-20-Million-in-Funding-to-Further-Personalize-Cancer-Therapy-With-Multimodal-AI