BASEL, Switzerland, June 12, 2026
Roche announced that the U.S. Food and Drug Administration (FDA) has approved the VENTANA PTEN (SP218) RxDx Assay, the first companion diagnostic designed to assess PTEN protein loss in patients with prostate adenocarcinoma. The approval enables clinicians to identify patients with PTEN-deficient tumors who may be eligible for treatment with TRUQAP® (capivasertib) in combination with abiraterone acetate, expanding precision medicine options for patients with advanced prostate cancer.
First FDA-Approved PTEN Companion Diagnostic Addresses Unmet Need
The newly approved VENTANA PTEN (SP218) RxDx Assay is the first immunohistochemistry-based companion diagnostic approved for determining PTEN protein loss in prostate cancer. PTEN is a critical tumor suppressor protein, and its loss is associated with more aggressive disease progression and reduced response to existing standard-of-care therapies. By accurately identifying PTEN-deficient tumors, the assay provides clinicians with an important tool to guide personalized treatment decisions and select patients who may benefit from targeted therapy with TRUQAP.
Supporting Precision Medicine in Metastatic Prostate Cancer
Approximately 25% of patients with metastatic hormone-sensitive prostate cancer exhibit PTEN deficiency, a biomarker linked to poor clinical outcomes. The FDA approval was supported by data from the CAPItello-281 Phase 3 clinical trial, where the assay was used to identify patients whose tumors demonstrated PTEN protein loss. Patients receiving TRUQAP in combination with abiraterone acetate achieved a statistically significant and clinically meaningful reduction in disease progression, highlighting the value of biomarker-driven treatment approaches in advanced prostate cancer..
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Roche Expands Leadership in Companion Diagnostics
The approval further strengthens Roche’s position as a leader in companion diagnostics and precision oncology. The assay will be available on Roche’s BenchMark ULTRA platform and is also being utilized by Foundation Medicine, a Roche affiliate specializing in comprehensive genomic profiling. With prostate cancer remaining one of the most common cancers among men worldwide, the availability of a validated PTEN companion diagnostic marks an important step toward expanding personalized treatment options and improving outcomes for patients with advanced disease.
Source: Roche, press release
