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PreciseDx Strikes Deal With Netherlands Pathology Lab to Study Breast Cancer Test

NEW YORK – PreciseDx said Tuesday it signed an agreement with the Laboratory of Pathology in Dordrecht, Netherlands, for a retrospective study on the performance of PreciseDx's assay for breast cancer risk.

New York City-based PreciseDx is a developer of cancer risk stratification tests, and the Laboratory of Pathology serves two hospitals in the Netherlands: Albert Schweitzer Hospital in Dordrecht and Beatrix Hospital in Gorinchem. PreciseDx said its Breast Test is designed to augment work by pathologists to provide more accurate prognoses and reduce breast cancer diagnostic misclassification.

Financial and other terms of the deal were not disclosed. PreciseDx reported in January it had raised $10.75 million in a Series A preferred financing round toward development and commercialization of its artificial intelligence-based cancer risk stratification technology.

The firm said its assay functions as a standalone prognostic tool for stratifying early-stage invasive breast cancer by low and high risk of recurrence within six years of diagnosis as well as reclassifying breast cancer histologic grades 2 and 3 into low-risk and high-risk categories. The company plans to evaluate the performance of the assay using early-stage breast cancer cases with known six-year clinical outcomes, starting with 300 digitally scanned hematoxylin and eosin images from patients with early-stage ductal and mixed ductal/lobular breast cancer.

Douglas Malinowski, PreciseDx's VP of clinical affairs, said in a statement, "In addition to the prognostic utility of predicting the likelihood of recurrence, this collaboration will also permit a comparison of the PreciseDx Breast assay with the prognostic performance of other available diagnostic tests in the identification of patients with low-risk and high-risk of disease recurrence." The project will also aid evaluation of the assay in a pathology workflow, he said.

Pieter Westenend, pathologist at the Laboratory of Pathology and principal investigator in the collaborative study, said in a statement that PreciseDx's turnaround time of "only a few days" provides an encouraging tool for prognostic analysis.