Posted by Michael Wonder on 16 Jun 2026
Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer
12 June 2026 - Roche announced today that the Ventana PTEN (SP218) RxDx Assay is the first immunohistochemistry companion diagnostic test to receive US FDA approval for determining PTEN protein loss, also known as PTEN deficiency, in tumours of patients with prostate adenocarcinoma.
These patients may now be eligible for treatment with AstraZeneca’s targeted therapy Truqap (capivasertib).
