Ataraxis AI's Laboratory Receives CAP Accreditation and California Clinical Laboratory License

NEW YORK--(BUSINESS WIRE)--Ataraxis AI, a frontier clinical artificial intelligence (AI) company developing AI-powered tools for oncology, today announced that its laboratory has received accreditation from the College of American Pathologists (CAP) and a clinical laboratory license from the State of California, expanding access to the Ataraxis Breast platform for clinicians and patients across the state.

CAP accreditation follows an on-site inspection by practicing pathologists covering clinical protocols, personnel qualifications, instrumentation, safety programs, and overall laboratory management. The CAP Laboratory Accreditation Program carries deeming authority from the Centers for Medicare & Medicaid Services (CMS), meaning the inspection stands in place of a CMS inspection under the Clinical Laboratory Improvement Amendments (CLIA).

The California license permits Ataraxis to receive and process specimens from patients in California, one of the largest oncology markets in the United States. With this approval, clinicians in California can now order Ataraxis Breast for their patients.

“With this approval, our first-in-class AI tools are now available for clinical use by the overwhelming majority of U.S. providers, including in California, where Ataraxis already has a large base of collaborators. We are excited to partner with physicians across the state who are leaders in adopting new technologies, and to work with their patients to provide the best possible care,” said Jan Witowski, MD, PhD, co-founder and CEO of Ataraxis AI.

Ataraxis Breast combines digitized H&E pathology slides with clinical data to generate patient-specific predictions across the continuum of early-stage breast cancer care—estimating individualized risk of recurrence, predicting benefit from adjuvant chemotherapy, and forecasting response to neoadjuvant therapy, all from a single specimen. CAP accreditation and California licensure support Ataraxis's continued expansion of clinical access to this platform nationwide.

About Ataraxis AI

Ataraxis AI is a clinical AI company building AI-powered tools to personalize cancer care. By integrating routine digital pathology with clinical data, Ataraxis aims to deliver individualized insights into prognosis and treatment benefit across multiple cancer types.

Ataraxis™ Breast is Ataraxis AI's flagship multimodal platform for breast cancer. Delivered as a suite of AI-powered clinical tests, it combines routine digital pathology with clinical data to generate predictions of recurrence risk and therapy response, supporting decision-making across the full continuum of care. The Ataraxis Breast platform was developed using 30,000+ multimodal patient cases and is designed to fit into existing pathology workflows without requiring additional tissue or specialized assays. All Ataraxis Breast tests are offered as laboratory-developed tests through a CLIA-certified and CAP-accredited laboratory. To learn more, visit ataraxis.ai.