Roche secures FDA approval for first companion diagnostic to detect PTEN protein status in prostate cancer patients

Roche has confirmed that the VENTANA PTEN (SP218) RxDx Assay has become the first immunohistochemistry-based companion diagnostic to win approval from the U.S. Food and Drug Administration for identifying PTEN protein loss, sometimes called PTEN deficiency, within tumours of patients diagnosed with prostate adenocarcinoma. Patients found to have this biomarker may now qualify for treatment with TRUQAP (capivasertib), AstraZeneca’s targeted therapy.

“Prostate cancer is one of the leading cancer diagnoses for men in the United States,” said Matt Sause, CEO of Roche Diagnostics. “The FDA approval of our new companion diagnostic will provide clinicians with a vital tool to identify patients with PTEN loss and potentially provide new therapeutic options.”

PTEN functions as a tumour suppressor protein, and its loss is a pattern frequently seen across numerous cancer types. With Roche’s new test, patients whose prostate cancer shows PTEN deficiency may become candidates for combination treatment involving TRUQAP, which now stands as a first-line option for those with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer, a category previously known as metastatic hormone-sensitive prostate cancer.

Metastatic hormone-sensitive prostate cancer represents a particularly aggressive disease course, and until now, no treatment had specifically targeted the biology underlying PTEN protein loss. Following a new diagnosis of metastatic prostate cancer, patients typically survive for an average of around 5 to 6 years. Roughly a quarter of those with metastatic hormone-sensitive prostate cancer carry PTEN-deficient tumours, as determined through immunohistochemistry testing.

Foundation Medicine, an independent affiliate within the Roche Group, is among the laboratories already using the VENTANA PTEN (SP218) RxDx Assay companion diagnostic kit to support healthcare providers in identifying patients with PTEN protein loss.

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Related Topics and Keywords

FDA Approval, Phase 3, prostate cancer, PTEN protein, Roche