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TEST:
VENTANA PTEN (SP218) RxDx Assay

Company:
Roche
Type:
FDA Approved (PMA)
Related tests:

Details

Evidence
News
The VENTANA PTEN (SP218) RxDx Assay is a qualitative immunohistochemical assay intended to be used in the assessment of PTEN protein in prostate adenocarcinoma. The OptiView DAB IHC Detection Kit is used for staining on a BenchMark ULTRA instrument. The assay is indicated as an aid in identifying patients with prostate adenocarcinoma who may be eligible for treatment with TRUQAP in combination with abiraterone acetate in accordance with the approved therapeutic product labeling.
Cancer:
Hormone Sensitive Prostate Cancer
Gene:
PTEN (Phosphatase and tensin homolog)
Drug:
Truqap (capivasertib)
Method:
Immunohistochemical assay
Approvals
Date
Cancer
Gene
Drug
By
06/12/26
FDA (PMA)