Caris Life Sciences vs Ibex Medical Analytics

Ibex Prostate Detect (Galen Second Read) was cleared as K241232 in January 2025. Urology Times, reporting on the FDA summary, cites a 99.6% positive predictive value for heatmap accuracy and says pathologists without the AI missed 13% of the cancers the AI found. Ibex sells to laboratories and health systems on enterprise contracts, so a pathology lab reading prostate biopsies is the buyer. The vendor lists breast, HER2 and gastric tools too.

A node-negative HR+ breast case is where Caris enters. MI Clarity applies AI and computational pathology to the H&E slide, with no sequencing, to estimate distant recurrence risk in early HR+/HER2- node-negative breast cancer, and the report goes to the treating oncologist. Caris's GPSai tissue-of-origin model has a 2025 paper in Cancer Research Communications. Ibex says its breast tools are not FDA cleared, so the prostate lab purchase and the breast recurrence report are separate decisions.