Ataraxis AI, a frontier clinical artificial intelligence (AI) company developing AI-powered tools for oncology, announced the launch of Ataraxis ARC (the Ataraxis Real-World Clinical Outcomes Registry), a prospective, multi-site, observational study. ARC is a first-of-its-kind prospective study of AI-based tools in oncology, linking AI tool predictions with real-world short- and long-term patient outcomes.

ARC will initially enroll approximately 1,000 patients across participating cancer centers over roughly two years, with follow-up extending up to 10 years per participant. Eligible patients are adults with a solid tumor malignancy, including breast cancer, who are undergoing Ataraxis testing as part of routine clinical care. Patients enroll only after an Ataraxis test has already been ordered for them; treatment decisions remain entirely at the discretion of the treating physician and are not directed or influenced by the registry. ARC follows outcomes such as recurrence, progression, survival, and treatment response over time and links them back to each patient's test results.

The registry uses an adaptable design, allowing Ataraxis-led analyses and investigator-initiated ancillary studies to be added after the initial registry opens. Qualified investigators at participating sites may request access to de-identified registry data to conduct their own independent research, broadening the scientific reach of the dataset over time.

“I am excited to see the activation of a prospective registry study, a first of its kind, for Ataraxis to further cement its role in the diagnostic work-up in early-stage breast cancer. Digital pathology classifiers of risk and defining biology accelerate the work-up, with the potential for higher accuracy and at lower cost and efficiency than standard gene expression assays. AI-based pathology tests are the way forward for equitable precision oncology. This critical prospective data will increase the adoption of Ataraxis into more patients' care,” said VK Gadi, MD, PhD, Deputy Director of the University of Illinois Cancer Center.

Ataraxis ARC extends Ataraxis’s evidence generation beyond retrospective validation, prospectively linking pathology-based predictions to the outcomes clinicians and patients care about most: recurrence, progression, survival, and treatment response. Enrollment begins with breast cancer patients tested on the Ataraxis Breast platform and is designed to expand to additional tumor types over time, supporting continued validation of the current platform, informing development of future Ataraxis tests, and giving independent investigators a path to ask their own questions of the data.