SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) announced that the VENTANA PTEN (SP218) RxDx Assay has become the first immunohistochemistry (IHC) companion diagnostic test to receive approval from the U.S. Food and Drug Administration (FDA) for determining PTEN protein loss, also known as PTEN deficiency, in tumours of patients with prostate adenocarcinoma. With this approval, patients identified with PTEN deficiency may now be eligible for treatment with AstraZeneca's targeted therapy TRUQAP (capivasertib).
The VENTANA PTEN (SP218) RxDx Assay is a qualitative immunohistochemical test designed to assess PTEN protein in prostate adenocarcinoma. Using the OptiView DAB IHC Detection Kit for staining on the BenchMark ULTRA instrument, the assay serves as an aid in identifying patients who may benefit from TRUQAP in combination with abiraterone acetate, in line with the approved therapeutic product labeling.
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