Paige received CE-IVD and UKCA marks for the Paige Prostate Biomarker Suite, an AI software designed to detect the presence of four prostate cancer biomarkers on digitized tissue images stained with hematoxylin and eosin. This is Paige’s first European regulatory certification of image-based biomarker detection on H&E-stained tissue samples.
As oncology enters a new era of precision medicine, the Food and Drug Administration’s evolving biomarker strategy aims to ensure that life-saving therapies are tailored to individual patient needs, fostering safer and more effective treatments. Historically, therapies were approved with broad indications based on overall efficacy, even when outcomes for biomarker-positive and -negative patients were...
