Roche Wins FDA Approval for First IHC Companion Diagnostic to Detect PTEN Protein Loss in Prostate Cancer
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SHERIDAN, WYOMING -- June 15, 2026 -- Roche has received FDA approval for the VENTANA PTEN (SP218) RxDx Assay, the first immunohistochemistry companion diagnostic cleared to assess PTEN protein loss in patients with prostate adenocarcinoma. The assay identifies patients whose tumours exhibit PTEN deficiency, making them potentially eligible for treatment with AstraZeneca's TRUQAP in combination with abiraterone acetate. Approval is based on results from the CAPItello-281 clinical study, where the assay served as the enrollment diagnostic to identify patients with PTEN-deficient tumours.