PreciseBreast has the potential to deliver significant savings to payers and patients, while providing a more accurate measure of clinical risk; ultimately supporting treatment and management decisions for all patients with invasive breast cancer

NEW YORK, July 23, 2024 /PRNewswire/ -- PreciseDx®, a leading innovator in oncology diagnostics leveraging Artificial Intelligence (AI) for revolutionary, morphology-driven disease analysis, today announced that its economic impact study for PreciseBreast™ risk assessment has been published in the July issue of the Journal of Medical Economics.

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The study calculated the cost impact of using PreciseBreast™(also referred to as PDxBr), an AI histopathology platform that predicts the 6-year risk of recurrence in early-stage invasive breast cancer (IBC) patients to aid in the treatment decision process (i.e. use of chemotherapy). The study compared the costs of treatment guided by standard of care (SOC) risk assessment (i.e., 21 gene expression test and histopathology assessment) versus PreciseBreast™ in conjunction with SOC. A hypothetical cohort of one million U.S. women with early-stage invasive breast cancer was used for the study.

Cost impact considered the cost of testing, adjuvant therapy, recurrence, adverse events, surveillance, and end-of-life care from a commercial payer perspective. The findings are compelling: when used as part of a recurrence risk evaluation in a hypothetical cohort of one million female members, use of PreciseBreast™ resulted in cost savings of $4M in year one compared to the current standard of care alone. Over 6 years, the savings increased to $12.5M. The per-treated patient costs calculated in year one were $19.5K for traditional standard of care and $16.9K for PreciseBreast™.

"We are very pleased with these findings and the potential impact on both healthcare costs and patient care," said Michael J. Donovan, Co-founder and Chief Medical Officer of PreciseDx. "With PreciseBreast, we are potentially shielding many low-risk patients from the unnecessary toxicity of chemotherapy, while also providing significant savings to payers. In addition, PreciseBreast is a digital prognostic test which relies on the patient's own readily available diagnostic tissue specimen from the pathology lab, ensuring accessibility to oncologists and pathologists regardless of geographic location."

PreciseBreast™ uses Artificial Intelligence (AI) and Machine Learning (ML) combined with its Morphology Feature Array (MFA®) to analyze invasive breast cancer 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.

"Our validated AI-powered MFA platform (using digital whole slide image analysis) is changing how we can assess and analyze patient data to positively impact healthcare," said Ted Diehl, Vice President of Commercial Development at PreciseDx. "For breast cancer patients and their physicians, PreciseBreast is providing accurate and objective risk stratification within 48 hours at 20% the cost of gene expression testing. PreciseBreast provides an accurate and effective sequence to gene expression testing and was established to enhance current histopathology assessment that is accessible, affordable, and easily available."

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™ is an early-stage invasive breast cancer risk assessment, independent of HER2, and hormone receptor status. The AI-powered test utilizes standard H&E pathology slide images. Leveraging millions of data points, PreciseBreast™ analyzes, correlates, and quantifies those critical features that predict 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). PDxBr will be available worldwide under the brand name of PreciseBreast™. For more information, please contact precisebreast@precisedx.ai.

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