First European regulatory clearance for Paige’s digital biomarker capabilities

May 12, 2022 10:05 AM Eastern Daylight Time

NEW YORK–(BUSINESS WIRE)–Paige, a global leader in clinical AI applications in pathology, today announced it received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, an AI software that is designed to detect the presence of four prostate cancer biomarkers on digitized tissue images stained with hematoxylin and eosin (H&E)*. This is the first European regulatory certification of image-based biomarker detection on H&E-stained tissue samples for Paige, potentially expanding the utility of AI to analyze tissues prepared with the most frequently used stain in histology.

“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”

In contrast to traditional molecular biomarker testing, image-based biomarkers can enable faster turnaround time for results, provide new information at the point of diagnosis and reduces the need for unnecessary and expensive testing on definite negatives, while protecting the integrity of the tissue sample. Specifically, the Paige Prostate Biomarker Suite can detect biomarkers from H&E-stained samples and can inform the need for confirmatory tests such as immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).

The Paige Prostate Biomarker Suite is designed to assist in the detection of Androgen Receptor (AR), TP53, RB1 and PTEN biomarkers that are associated with the development and progression of prostate cancer. The biomarkers can help physicians stratify patients into treatment paradigms and direct targeted enrollment into clinical trials. The Paige Prostate Biomarker Suite was developed using the same underlying technology from Paige Prostate Detect, which was developed with histology image data from tens of thousands of patients and is already CE-IVD and UKCA marked, in addition to being approved by the FDA in the U.S.

“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,” said Jill Stefanelli, Ph.D., President and Chief Business Officer at Paige. “We’re excited by this regulatory milestone of our biomarker capabilities built on our robust AI technology platform, which can rapidly screen and develop proof-of-concept biomarkers. As we expand our biomarker portfolio, we also look forward to developing novel biomarkers across indications to identify patients that should receive genomic testing or could potentially respond to targeted therapies. This opens the door to a whole new range of biomarker applications and, in turn, new opportunities for industry collaboration.”

*In the United States, Paige Prostate Biomarker Suite is available for Research Use Only and not for use in diagnostic procedures.

About Paige
Paige was founded in 2017 by Thomas Fuchs, Dr.Sc., David Klimstra, M.D., and colleagues from Memorial Sloan Kettering Cancer Center (MSK). The company builds computational pathology products designed so patients and their care teams can make effective, more informed treatment decisions. With this new class of AI-based technologies positioned to drive the future of diagnostics, Paige created a platform to deliver this novel technology to pathologists to transform their workflow and increase diagnostic confidence and productivity. Paige’s products deliver insights to pathologists and oncologists so they can arrive efficiently at more precise diagnoses for patients. Paige is the first company to receive FDA approval for an AI-based digital pathology product.