FDA approves the first companion diagnostic to assess PTEN protein in people living with prostate cancer
Roche's VENTANA PTEN (SP218) RxDx Assay has received FDA approval, enabling detection of PTEN protein loss in prostate tumors, guiding targeted therapy with AstraZeneca's TRUQAP for eligible patients.
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 tumors of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca’s targeted therapy TRUQAP (capivasertib).
Roche’s test enables patients with PTEN-deficient prostate cancer to access 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).
Foundation Medicine, an independent affiliate of the Roche Group, is one laboratory using the VENTANA PTEN (SP218) RxDx Assay companion diagnostic kit to help healthcare providers identify patients with PTEN protein loss.
