Roche announced FDA approval for the VENTANA PTEN (SP218) RxDx Assay. This is the first immunohistochemistry companion diagnostic test for PTEN protein loss in prostate cancer. It identifies patients who may benefit from combination treatment with AstraZeneca's TRUQAP. PTEN protein loss is linked to faster disease progression and poorer outcomes with standard treatments. This approval marks a significant step in personalized healthcare for prostate cancer patients. TRUQAP offers a new first-line treatment option for PTEN-deficient metastatic prostate cancer. Previously, treatments specifically targeting this PTEN protein loss biology were unavailable. Approximately 25% of metastatic hormone-sensitive prostate cancer patients have PTEN-deficient tumors. Foundation Medicine is one laboratory utilizing this diagnostic kit. The assay's approval was based on the CAPItello-281 clinical study results.