en.Wedoany.com Reported - The U.S. Food and Drug Administration (FDA) has approved the VENTANA PTEN (SP218) RxDx assay for marketing. This immunohistochemical companion diagnostic test is the first to be approved for determining PTEN protein loss in prostate adenocarcinoma, aimed at identifying patients who may be suitable for treatment with capivasertib (TRUQAP) in combination with abiraterone acetate.

PTEN is a tumor suppressor protein, and its loss is associated with faster disease progression and reduced benefit from standard therapies. The approved indication covers patients with PTEN-deficient metastatic androgen pathway unregulated or sensitive (mAPMN/S) prostate cancer, a population previously described as metastatic hormone-sensitive prostate cancer.

The approval is supported by the CAPItello-281 Phase III study, which used this assay for enrollment. Patients treated with TRUQAP in combination with abiraterone, selected through this assay, showed a statistically and clinically significant slowing of disease progression. The clinical threshold for PTEN protein loss is defined as ≥90% viable malignant cells showing no specific cytoplasmic staining.

Foundation Medicine is listed as an independent reference laboratory using the VENTANA PTEN (SP218) RxDx assay. The test is performed on the BenchMark ULTRA instrument using the OptiView DAB IHC Detection Kit for staining.

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