PreciseDx Receives New York State Approval For An AI-Enabled Breast Diagnostic
Test leveraging revolutionary Morphology Feature Array™ technology for patient-specific analysis, to be commercially available to patients and healthcare providers in the state this year
New York, NY /PRNewswire/ - PreciseDx, a leading innovator in AI-powered, patient-specific disease analysis, today announced that the New York State Department of Health (NYSDOH) has approved the PDxBr, a Lab Developed Test (LDT) designed to enrich breast cancer grading and improve risk categorization. With this approval, PreciseDx can now begin commercially testing patient samples in the state of New York through its CLIA certified laboratory.
The Clinical Laboratory Evaluation Program (CLEP) Assay Validation Review is considered one of the most important and rigorous levels of validation for LDTs. Each LDT submitted to the NYSDOH must undergo review for analytical and clinical performance, as well as reproducibility.
"We are pleased to receive the approval from the New York State Department of Health for our PDxBr breast test. This approval marks a significant regulatory milestone for our company and is a key step on our journey to commercialization," said Wayne Brinster, CEO of PreciseDx.
"Consistent with our mission of improving healthcare, PDxBr has shown to be an effective prognostic tool to further improve risk stratification over current histopathology methods."
In December 2022, data from PreciseDx was published in Breast Cancer Research. The study detailed that the PDxBr breast test enriches breast cancer grading and improves risk categorization. The assay was developed leveraging the power of the PreciseDx Platform and the AI-driven Morphology Feature Array™. This technology has now proven the ability to enhance pathology interpretation with objective, quantifiable, and highly accurate data. This data, which was also part of the submission to New York State, provides more robust information regarding patient disease status, and represents the next generation of pathology analysis.
"The recent clinical validation of the PDx breast test has provided a significant advancement in the characterization of invasive breast cancer through the use of AI," said Michael J. Donovan, PhD MD CMO and Co-Founder of PreciseDx. "Now, with the recent approval from the New York State Department of Health, the testing platform will soon be available to providers and patients throughout the state."
PreciseDx is a leading innovator in AI-powered, patient-specific disease analysis. PreciseDx's Morphology Feature Array™ provides clinical teams with unmatched information and accurate, actionable intelligence for disease state characterization, supporting personalized patient management. To learn more about PreciseDx, visit https://precisedx.ai/
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