Paige, a developer of clinical AI applications in pathology, has received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, an AI software that detects the presence of four prostate cancer biomarkers on digitized tissue images stained with hematoxylin and eosin (H&E).
The company said this is its first European regulatory certification of image-based biomarker detection on H&E-stained tissue samples, potentially expanding the utility of AI to analyze tissues prepared with the most frequently used stain in histology. In the United States, the software is available for Research Use Only and not for use in diagnostic procedures.
The Paige Prostate Biomarker Suite assists in detecting Androgen Receptor (AR), TP53, RB1, and PTEN biomarkers, which 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 software 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 FDA.
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 reduce the need for unnecessary and expensive testing on definite negatives, while protecting the integrity of the tissue sample, according to the company. 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).
“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, in prepared remarks. “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.”
Stefanelli concluded, “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.”