PreciseDx, a provider in AI-powered, patient-specific disease analysis, 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,” says 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 published in Breast Cancer Research 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 is designed 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, the company says.

“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,” says 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.”