COTA, Baptist Health South Florida and PreciseDx have initiated a collaborative effort to evaluate the AI-enabled PreciseBreast (PDxBr) test performance.
The test is designed to predict the probable recurrence of invasive breast cancer (IBC).
PDxBr is an early-stage invasive breast cancer risk assessment. It leverages standard H&E pathology slide images to deliver a Risk of Recurrence Score, utilising a vast array of data points for its predictive analysis.
The partnership aims to leverage curated real-world data to analyse the clinical risk tool’s performance against traditional pathology reviews and 21-gene assay results.
The validation study’s success could lead to Baptist Health South Florida offering the PDxBr test to IBC patients.
This test has a rapid 48-hour turnaround for results and an 80% reduction in cost, representing significant advancements in patient care and resource management.
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PreciseDx’s AI-driven approach to oncology diagnostics utilises the patented Morphology Feature Array (MFA) to provide comprehensive insights into disease progression, aiding in more informed clinical decision-making.
The test can operate independently of HER2, hormone, and node status.
COTA chief medical officer Dr C K Wang said: “AI has the potential to augment human learning and improve the accuracy and precision of cancer diagnostics and treatments.
“It is critical that we evaluate these tools against the current standard of care to validate their efficacy and build trust in AI and new technologies.”
Meeting the stringent Clinical Laboratory Improvement Amendments (CLIA) standards, the test has also passed by the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) Assay Validation Review.
With the brand name PreciseBreast, PDxBr is set to be available globally.
Last month, PreciseDx collaborated with UCLA’s Department of Pathology and Laboratory Medicine in Los Angeles on sponsored research to evaluate PDxBr’s ability to accurately assess the risk of recurrence for patients with triple-negative breast cancer.
