Artera, a precision medicine company specializing in AI-driven cancer tests, has obtained a California laboratory license, enabling wider availability of its ArteraAI Prostate Test. This test offers both prognostic and predictive capabilities for localized prostate cancer, empowering clinicians and patients in California to make more informed treatment decisions starting October 10, 2024.
Significance of California License
The California Department of Public Health (CDPH) license marks a crucial step for Artera, granting access to one of the largest healthcare markets in the United States. Andre Esteva, CEO and co-founder of Artera, emphasized the importance of this milestone, stating, "Receiving the California lab license is a significant milestone for Artera, allowing us to serve more patients and clinicians across the U.S." With the American Cancer Society estimating over 26,000 new prostate cancer diagnoses in California alone, the ArteraAI Prostate Test aims to provide accessible AI-powered precision medicine.
ArteraAI Prostate Test: A Dual-Purpose Biomarker
The ArteraAI Prostate Test stands out as the first test capable of predicting therapy benefit and forecasting long-term outcomes in patients with localized prostate cancer. This dual functionality addresses a critical need for personalized treatment strategies. The test employs a multimodal artificial intelligence (MMAI) algorithm that integrates digital images from a patient’s biopsy with their clinical data. This comprehensive analysis enables a more accurate determination of prognosis and prediction of therapy response, validated across multiple Phase 3 randomized trials.
Clinical Validation and Expert Opinion
Peter Carroll, MD, MPH, Professor of Urology at the University of California, San Francisco, highlighted the test's potential impact: "Artera’s predictive biomarker recognized in national guidelines for localized prostate cancer has the potential to significantly empower treatment decisions, including patients considering androgen deprivation therapy (ADT) in combination with radiation." He further emphasized the importance of providing clinicians and patients with access to extensively validated technologies to ensure optimal, personalized care.
Commitment to Quality and Safety
Prior to receiving the California license, Artera achieved accreditation from the College of American Pathologists (CAP) in August. The CAP accreditation process involves rigorous inspection of laboratory staff qualifications, equipment, facilities, safety programs, and overall management. These certifications demonstrate Artera’s dedication to maintaining the highest standards of quality and patient safety.
How the Test Works
The ArteraAI Prostate Test leverages a unique algorithm that assesses digital images from a patient’s biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials.
Artera's laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera’s laboratory in Jacksonville, Florida, and can be ordered online at Artera.ai.
