Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer

▤ Summary

Roche secured FDA approval for VENTANA PTEN (SP218) RxDx Assay, the first immunohistochemistry companion diagnostic for assessing PTEN protein loss in prostate adenocarcinoma. The test helps identify patients who may benefit from AstraZeneca’s TRUQAP in combination with abiraterone acetate. Roche positions the approval as evidence of its strength in companion diagnostics and personalized healthcare. The approval is based on the CAPItello-281 study and opens a new testing option for a patient group with limited targeted treatment choices.

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