The tool uses digitized pathology slides to estimate how patients will respond to therapy before surgery.
Ataraxis AI released Ataraxis Breast NEO, a predictive test designed to estimate the likelihood of pathologic complete response (pCR) following neoadjuvant therapy in patients with early-stage breast cancer.
The test is performed using a core needle biopsy pathology slide collected at the time of initial diagnosis, before treatment decisions are finalized. From this single specimen, clinicians receive a patient-specific likelihood of treatment response across all major breast cancer subtypes, including HER2-positive and triple-negative breast cancer. These populations are among the most likely to receive neoadjuvant therapy, making pCR a clinically significant metric.
Clinical Validation and Development
Developers used multimodal data from more than 1,000 breast cancer patients worldwide to build the test. It was clinically validated in more than 1,500 patients through several observational real-world studies and prospective clinical trials.
A patient’s response to neoadjuvant therapy has a significant impact on long-term outcomes and informs surgical and systemic treatment decisions. Patients who achieve a pathologic complete response often have better survival outcomes than those who do not respond. Currently, the decision to pursue neoadjuvant therapy and the selection of specific regimens are often guided by population-level response rates. These rates can vary based on disease stage, regimen, and molecular profile.
“With the launch of Ataraxis Breast NEO, we have expanded our ability to help breast cancer patients not just in the adjuvant setting, but also in the neoadjuvant setting. Ultimately, we want Ataraxis Breast to become the platform that can answer all important questions about therapy selection for breast cancer patients and personalize the entire treatment plan from the very beginning,” says Jan Witowski, MD, PhD, ceo and co-founder of Ataraxis AI, in a release.
Integration into the Breast Suite
Ataraxis Breast NEO is a new capability within the company’s broader breast platform, which also includes Ataraxis Breast RISK for individualized recurrence risk and Ataraxis Breast CTX for predicting adjuvant chemotherapy benefit. These tests combine digitized hematoxylin and eosin (H&E) pathology slides with clinical data to generate predictions for individual patients.
The suite of tests is designed to support clinical decision-making at multiple stages of care, from the initial biopsy through adjuvant therapy. This approach allows clinicians to access treatment planning information without exhausting tissue samples or requiring extended wait times for results.
According to the company, the ability to identify which patients are more or less likely to respond to neoadjuvant therapy is increasingly important as more treatment options become available for breast cancer patients. By providing patient-specific predictions, the platform aims to assist in the selection of the most appropriate treatment regimens.
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