On March 14, 2024 Prelude Corporation (PreludeDx), a leader in precision diagnostics, reported data from an analysis of over 700 early-stage invasive breast cancer patients for AidaBreast – a novel biosignature that predicts 10-year recurrence rate and radiation therapy (RT) benefit – at the 41st Annual Miami Breast Cancer Conference (MBCC) (Press release, PreludeDx, MAR 14, 2024, View Source [SID1234641183]).

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Building on the clinical adoption of the company’s initial test offering, DCISionRT, which predicts radiation benefit for patients with ductal carcinoma in situ (DCIS), AidaBreast will provide personalized testing to the larger Stage I and IIA breast cancer market. AidaBreast is powered by a multi-omic platform utilizing proteomic and genomic analyses, and offers a unique, differentiated approach to determine individual patient risk profiles. The first test in the AidaBreast portfolio will be for the assessment of radiation therapy benefit.

"We are very encouraged by the predictive data presented at the Miami Breast Cancer Conference. We look forward to the launch of AidaBreast to initially assist with radiation treatment decisions, and soon after to help answer additional therapeutic questions, so that we can significantly increase our clinical impact in the broader breast cancer market," said Dan Forche, President and CEO of PreludeDx. "Our focus remains on delivering precision diagnostics to enhance shared decision-making between physicians and their patients."

The poster entitled, ‘A Novel Biosignature for Early-Stage Invasive Breast Cancer to Predict Radiotherapy Benefit and Assess Recurrence Risk for Patients Treated with Breast-Conserving Surgery’, demonstrates the potential of the assay to predict radiation benefit in over 700 patients diagnosed with hormone receptor-positive, HER2-negative, Stage I, IIA, node negative, no evidence of metastasis breast cancer who underwent breast conserving surgery (BCS) with or without RT. The biosignature identified clinically meaningful risk groups with differential RT benefit associated with 10-year recurrence rate. The identified low-risk group had a recurrence rate of 1% with or without RT. The elevated risk group had a recurrence rate of 20% without RT and 13% with RT. The residual risk group had a recurrence rate of 30% with or without RT.

"While tests for predicting the benefit of chemotherapy and endocrine therapy currently exist for early-stage breast cancer patients, AidaBreast addresses the gap for assessing radiation therapy benefit," said Chirag Shah, MD, radiation oncologist at Cleveland Clinic, co-director of the comprehensive breast cancer program, and director of breast radiation oncology. "The test fills a long-needed void in providing better tools which can optimize shared treatment decision-making based on each patient’s unique biology."

PreludeDx Additional Poster Presentations at MBCC 2024:

A Comparative Analysis of Changes in Treatment Recommendation for Black and White Patients with Ductal Carcinoma in Situ Using a 7-Gene Predictive Biosignature: Analysis of the PREDICT Study

Limitations in the Application of Clinicopathologic Factors Alone in Predicting Radiation Benefit for Women with Low-Risk DCIS after Breast Conserving Surgery: The Impact of a 7-Gene Biosignature Based on 10-year Ipsilateral Breast Recurrence (IBR) Rates

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.