NEW YORK ─ Computational pathology company Paige said on Tuesday that it has obtained CE marking for its Paige Breast cancer detection software, which directs pathologists to suspicious areas for further evaluation of breast biopsies.
The New York-based company further announced it obtained CE marking for Paige Prostate Grading & Quantification, a digital diagnostic test that offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.
Both products are available for use in laboratories and hospitals in the European Economic Area, Switzerland, and the UK.
"The CE mark in breast cancer represents an important regulatory validation for our computational pathology products as we broaden our applications in oncology, while the CE mark in prostate cancer adds valuable grading and quantification features for our existing CE marked Paige Prostate offering," Leo Grady, CEO of Paige, said in a statement.
Paige Breast is designed to draw pathologists’ attention to concerning features on a breast tissue slide and provides slide and case-level predictions about the presence of cancer. This functionality enables pathologists to more easily, efficiently, and confidently identify small foci of cancer that can be easily missed, Paige said.
With the addition of the new grading and quantification functionality, Paige Prostate can enhance diagnostic confidence for the pathologist while increasing consistency and standardization, the firm said.
Paige, founded in 2017 by researchers at Memorial Sloan Kettering Cancer Center, is developing commercial applications based on computational pathology technology it has licensed from MSKCC. In November 2019, the company announced it obtained CE marking for its artificial intelligence-based prostate cancer detection solution and pathology viewer.