Artera to Highlight AI-Based Cancer Risk Stratification at ASCO 2026

The presentations include two breast cancer studies evaluating the platform across distinct clinical scenarios, along with additional research in localized prostate cancer examining model performance and biological associations. Together, the findings highlight the potential of routinely available clinical materials to support risk stratification and chemotherapy benefit assessment.

One breast cancer study, selected for oral presentation at ASCO 2026, externally validates MMAI for prognosis and chemotherapy benefit prediction in postmenopausal patients with node-positive, hormone receptor-positive disease. A breast cancer poster presentation also compares MMAI’s prognostic performance with the 21-gene Recurrence Score test in early-stage, node-negative disease. The analysis reports strong concordance in identifying low-risk patients with favorable outcomes, while showing that MMAI may provide added prognostic clarity in low- and intermediate-risk groups using digital pathology images without consuming additional tissue.

In addition to breast cancer, Artera will present localized prostate cancer data at ASCO 2026. One poster shows that image-only and multimodal AI digital pathology biomarkers derived from routine pathology can consistently stratify metastatic risk across multi-institutional, real-world cohorts, despite differences in standard management strategies. Another exploratory poster assesses clinical and biological associations between MMAI and a 22-gene genomic classifier, noting that both correlate with outcomes but often assign risk differently. The work builds on prior validation in an Asian patient cohort, further supporting performance across diverse populations.

The MMAI approach combines a patient’s digitized histopathology images with clinical data to estimate tumor aggressiveness and predict therapy benefit. The platform has been validated in multiple Phase 3 randomized trials across different cancers. It is available in multiple versions and is designed to support decision-making without requiring additional tissue beyond standard pathology.

Recent regulatory milestones highlighted alongside the ASCO presentations include U.S. Food and Drug Administration (FDA) authorization for ArteraAI Prostate through the de novo pathway and 510(k) clearance for ArteraAI Breast, a software‑as‑a‑medical‑device (SaMD) for risk stratification in early-stage HR-positive, HER2‑negative invasive breast cancer. The company has also received CE Marking for its prostate and breast in vitro diagnostic tests. These authorizations underscore the platform’s regulated availability in select markets.

“These studies expand our understanding of how Artera performs across increasingly complex breast cancer populations. Together, they reinforce the ability of MMAI to provide more refined risk assessment in both node-negative and node-positive disease and further support treatment decision-making for clinicians and patients,” said Calvin Chao, MD, PhD, Vice President of Medical Science at Artera.

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