#United States #Houston #Breast Cancer #Delphi Diagnostics #EAIRR

Delphi Diagnostics Publishes New Findings in European Journal of Cancer

In an important development for breast cancer diagnostics, Delphi Diagnostics has announced the publication of new clinical data in the prestigious European Journal of Cancer. This study validates the Endocrine Activity Index™ Recurrence Risk (EAIRR) as a crucial independent predictor for outcomes in patients suffering from hormone receptor-positive, node-positive breast cancer. The publication is titled, Combination of predicted sensitivity to endocrine therapy (SET2,3 index) and the Recurrence Score in node-positive breast cancer: Independent validation in the PACS-01 trial.

Key Findings from the Study

The research involved the analysis of 659 patient samples from the PACS-01 clinical trial, establishing that EAIRR enhances prognostic and predictive information - going beyond the previously established 21-gene Recurrence Score (RS). The study highlighted several key findings:

• - Statistical Significance: EAIRR adds substantially meaningful prognostic information when compared with the Recurrence Score.
• - Independent Prognostic Value: Both the Endocrine Activity Index (EAI) and EAIRR demonstrated their ability to independently predict patient outcomes.
• - Prospective Validation: This marks the second independent prospective clinical trial that confirms EAIRR’s capacity to refine risk stratification in patients with node-positive HR+ breast cancer, achieving Level 1B evidence.
• - Special Patient Groups: The study successfully included premenopausal women and patients with four or more positive lymph nodes, underscoring the prognostic capabilities of EAI/EAIRR in these categories.
• - Predicting Treatment Benefit: The EAI effectively predicted the benefits of adjuvant endocrine therapy (ET) as opposed to patients who did not undergo ET, signifying a p-interaction of less than 0.001.

These emerging findings position EAI as a distinctive biomarker that accurately reflects endocrine biology—an increasingly vital factor in determining long-term outcomes for breast cancer patients. EAIRR adds vital independent prognostic insights that can inform critical management decisions.

Expert Insights

Dr. Federico A. Monzon, Chief Medical Officer at Delphi Diagnostics, emphasized the impact of this publication: “This provides strong independent validation of EAIRR, establishing Level 1B evidence that it adds essential prognostic information. Moreover, it underscores our tool’s ability to furnish clinically actionable biological data not captured by current assays.” Dr. Monzon further noted that the data illustrates how EAI can guide personalized treatment selections for breast cancer patients.

About the Endocrine Activity Index (EAI)

Delphi Diagnostics’ Endocrine Activity Index is designed to deliver actionable insights for the prognosis and prediction of benefits from dose-intense taxane-based chemotherapy in stage II-III, HR+ HER2- breast cancer. The EAI assesses the endocrine activity within a breast tumor, and for prognostic purposes, it incorporates adjustments based on molecular subtype genes (RNA4) as well as clinical factors such as tumor size and regional lymph node status. Several studies have shown that the EAI serves as a reliable prognostic marker for long-term outcomes in patients with stage II-III breast cancer and is independent of alternate prognostic assessments.

About Delphi Diagnostics

Delphi Diagnostics Inc. is a Texas-based enterprise dedicated to the advancement of clinically validated tests aimed at improving the prognosis and treatment prediction for breast cancer. The company holds an exclusive license from The University of Texas MD Anderson Cancer Center to commercialize the Endocrine Activity Index, a technology pioneered by Dr. W. Fraser Symmans. Delphi's vision is to facilitate access to the EAI test for breast cancer patients, shaping new avenues for personalized treatment strategies. For additional information, visit www.delphi-diagnostics.com.