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.
GammaTile showed superiority in the primary endpoint of the study. Patients who received GammaTile lived longer without tumor regrowth, reducing the risk of either tumor recurrence or death by 50% reduction compared to standard of care, according to interim results from the ROADS clinical trial, which evaluated GammaTile versus standard of care in patients with operable, newly diagnosed brain metastases.
