PreciseDx's "Analytical Validation of a Digital Breast Cancer Test Predicting Recurrence in Early-Stage Breast Cancer" Featured in Clinical Breast Cancer

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Nov 07, 2023, 08:30 ET

PreciseBreast™ assessment demonstrates ability to predict the recurrence of early-stage breast cancer within 6 years

NEW YORK, Nov. 7, 2023 /PRNewswire/ -- PreciseDx®, a leading innovator in oncology diagnostics, leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven, disease analysis, today announced that its analytical validation study for its PreciseBreast™ assessment has been published in the November 3, 2023 issue of Clinical Breast Cancer.

As part of the validation, PreciseDx conducted a series of first-in class analytical studies, including precision, repeatability, reproducibility, and interference to assess methodological variability on the PreciseBreast™ (PDxBR) composite risk score. Collectively, these studies demonstrated an analytical performance that accurately predicts early-stage breast cancer risk of recurrence within 6 years.

Michael J. Donovan, PhD MD Co-founder and Chief Medical Officer of PreciseDx commented, "This accomplishment marks a crucial milestone in our ongoing mission to empower individuals and healthcare professionals with the latest advancements in breast cancer management. With PDxBR, clinicians will have additional precision data to support their treatment recommendations. The importance of these results is the demonstration of reliability for an assessment process that has the potential to improve accessibility and standardization to breast cancer patients around the globe and ultimately elevate the standard of care for patients."

The PreciseBreast™ Assay uses artificial intelligence (AI) and machine learning combined with its morphology feature array® to analyze invasive breast cancer (IBC) histology images with the purpose of enhancing and improving the traditional grading approach. PreciseBreast™ is an in vitro prognostic test that predicts breast cancer recurrence for patients diagnosed with early-stage IBC. This latest study builds upon PreciseDx's earlier clinical validation study published in Breast Cancer Research (cited 2022 Dec 21, 24:93. Available from: https://pubmed.ncbi.nlm.nih.gov/36539895/).

"I am tremendously proud of our team's dedication and their significant achievements to date," said Wayne Brinster, CEO of PreciseDx. "Our innovative digital assessment holds immense promise in enhancing early-stage breast cancer recurrence prediction, ultimately improving patient care and outcomes. We are determined to continue driving progress in the field of oncology and making a meaningful difference in the lives of those affected by this disease."

Notably this latest validation study shows potential for the standardization of breast cancer grading, which will allow for greater healthcare equity and the best possible treatment for all patients.

Earlier this year, New York State Department of Health (NYSDOH) approved the PreciseBreast™ Lab Developed Test (LDT). With this approval, PreciseDx can accept patient samples in the state of New York through its CLIA certified laboratory.

About PreciseDx®

PreciseDx® is innovating oncology diagnostics, leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven, disease analysis. Combining AI with our patented Morphology Feature Array® (MFA), PreciseDx provides access to unmatched disease insights and accurate, actionable intelligence for more comprehensive decision-making throughout the cancer care continuum. To learn more about PreciseDx, visit https://precisedx.ai

About PreciseBreast™

PreciseBreast™ (PDxBR) is an early-stage invasive breast cancer risk assessment independent of Her2, hormone, and node status. The AI-Powered test collects millions of data points, analyzes, correlates, and quantifies those which are critical features of predicting breast cancer recurrence and delivers a Risk of Recurrence Score. The Test meets the rigorous Clinical Laboratory Improvement Amendments (CLIA) standards and has passed the Clinical Laboratory Evaluation Program (CLEP) Assay Validation Review by the New York State Department of Health (NYSDOH). For more information, please contact [email protected].

SOURCE PreciseDx