The accreditation and licensure expand clinical access to the company’s AI-powered breast cancer platform.
Ataraxis AI announced its laboratory received accreditation from the College of American Pathologists (CAP) and a clinical laboratory license from the state of California. The approvals expand access to the Ataraxis Breast platform for clinicians and patients across the state.
The CAP accreditation follows an on-site inspection by practicing pathologists that covered 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 allows Ataraxis to receive and process specimens from patients in the state, which the company identifies as one of the largest oncology markets in the US. 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 US providers, including in California, where Ataraxis already has a large base of collaborators,” says Jan Witowski, MD, PhD, co-founder and CEO of Ataraxis AI, in a release. “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.”
The Ataraxis Breast Platform
Ataraxis Breast combines digitized H&E pathology slides with clinical data to generate patient-specific predictions for early-stage breast cancer care. From a single specimen, the platform estimates individualized risk of recurrence, predicts benefit from adjuvant chemotherapy, and forecasts response to neoadjuvant therapy.
The platform was developed using more than 30,000 multimodal patient cases and is designed to fit into existing pathology workflows without requiring additional tissue or specialized assays. According to the company, all Ataraxis Breast tests are offered as laboratory-developed tests through a CLIA-certified and CAP-accredited laboratory.
ID 242975569 | Accreditation Stamp © David Burke | Dreamstime.com
