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Paige Gets CE-IVD Mark, UK Regulatory Approval for Breast Cancer Biomarker Software

NEW YORK — Paige said on Friday that it has received CE-IVD and UK Conformity Assessed (UKCA) marks for its HER2Complete breast cancer biomarker detection software.

HER2Complete uses artificial intelligence to detect human epidermal growth factor receptor 2 (HER2) expression based on protein and mRNA levels on digital images of hematoxylin and eosin-stained tissue samples.

According to the New York City-based company, recent data suggest that there may be breast cancer patients whose tumors are considered negative for HER2 by standard immunohistochemistry and fluorescence in situ hybridization testing but may actually have low or ultra-low levels of the cancer-promoting protein. As a result, these patients could potentially benefit from HER2-targeting therapies.

Paige said that HER2Complete demonstrated the ability to detect levels of HER2 expression in HER2-negative and HER2-low tissue samples in a recent clinical study.

"We believe that this assay will allow us to reliably identify increased likelihood of HER2 expression, even on samples where HER2 expression was misclassified by legacy diagnostics as low or null," Paige Founder and Chief Medical Officer David Klimstra said in a statement.

Paige said it intends to assess the clinical utility of HER2Complete with multiple partners. The assay remains available for research use only in the US.

Last month, Paige received CE-IVD and UKCA marks for its Prostate Biomarker Suite of prostate cancer biomarker detection software.