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Paige Obtains CE Mark, UK Regulatory Approval for Prostate Cancer AI Software

NEW YORK ─ Digital pathology firm Paige on Thursday announced it has received CE-IVD and UK Conformity Assessed (UKCA) marking for its Prostate Biomarker Suite, an artificial intelligence software that detects four prostate cancer biomarkers on digitized tissue images stained with hematoxylin and eosin (H&E), the most frequently used stain in histology.

New York City-based Paige said the approvals represent its first European regulatory certifications for image-based biomarker detection on H&E-stained tissue samples and has the potential to expand the utility of AI to analyze tissues prepared with an H&E stain.

"By employing Paige Prostate Biomarker Suite, clinicians can rapidly reduce laboratory turnaround time while providing a broader range of data at the point of diagnosis," Paige President and Chief Business Officer Jill Stefanelli said in a statement.

The software assists in the detection of androgen receptor (AR), TP53, RB1, and PTEN biomarkers, which are associated with the development and progression of prostate cancer. It can help physicians stratify patients into treatment paradigms and direct targeted enrollment into clinical trials, Paige said.

Further, the software can inform the need for confirmatory tests such as immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH), Paige added.

To develop the software, the company used technology that also provided the basis for Paige Prostate Detect, which was developed with histology image data from tens of thousands of patients and is CE-IVD and UKCA marked, as well as approved by the US Food and Drug Administration.

In April, the firm announced it had received CE-IVD marking and UK regulatory approval for its Paige Breast Lymph Node artificial intelligence software.

The UK plans to recognize CE-IVD marking until July 2023, and thereafter will require that medical device and diagnostic test developers obtain the UKCA mark to enable the marketing of the product in the UK.