June 16, 2026- Roche announced that the VENTANA PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive U.S. Food and Drug Administration (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).
PTEN is a tumour suppressor protein and loss of PTEN is commonly observed in a variety of cancers. Roche’s test enables patients with PTEN-deficient prostate cancer to potentially benefit from a combination treatment with TRUQAP. TRUQAP provides a new, first-line treatment option for patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC).
Metastatic hormone-sensitive prostate cancer is an aggressive form of prostate cancer and treatments specifically targeting the PTEN protein loss biology were previously not available.