PMA P250031
- Device
- VENTANA PTEN (SP218) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- PMA number
- P250031
- Product code
- SHF
- Decision date
- 2026-06-12
- Classification
- Pathology
- Generic name
- Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN)
- Approval order statement
- VENTANA PTEN (SP218) RxDx Assay is a qualitative immunohistochemical (IHC) assay using rabbit monoclonal anti-PTEN, clone SP218, intended for laboratory use in the assessment of phosphatase and tensin homolog (PTEN) protein in formalin-fixed paraffin-embedded (FFPE) prostatic adenocarcinoma tissue specimens by light microscopy. The assay is for use with OptiView DAB IHC Detection Kit on a BenchMark ULTRA instrument. The assay is indicated as a companion diagnostic to aid in identifying patients who may be eligible for treatment with TRUQAP (capivasertib) in combination with abiraterone acetate in accordance with the approved therapeutic product labeling. The clinical cutoff for PTEN Loss status is >=90% of viable malignant cells with no specific cytoplasmic staining.Test results should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This product is intended for in vitro diagnostic (IVD) use.
Current openFDA PMA Record#
- Device
- VENTANA PTEN (SP218) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- PMA number
- P250031
- Product code
- SHF
- Generic name
- Immunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN)
- Decision date
- 2026-06-12
- Decision code
- APPR
- Date received
- 2025-08-18
- Approval order statement
- VENTANA PTEN (SP218) RxDx Assay is a qualitative immunohistochemical (IHC) assay using rabbit monoclonal anti-PTEN, clone SP218, intended for laboratory use in the assessment of phosphatase and tensin homolog (PTEN) protein in formalin-fixed paraffin-embedded (FFPE) prostatic adenocarcinoma tissue specimens by light microscopy. The assay is for use with OptiView DAB IHC Detection Kit on a BenchMark ULTRA instrument. The assay is indicated as a companion diagnostic to aid in identifying patients who may be eligible for treatment with TRUQAP (capivasertib) in combination with abiraterone acetate in accordance with the approved therapeutic product labeling. The clinical cutoff for PTEN Loss status is >=90% of viable malignant cells with no specific cytoplasmic staining.Test results should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This product is intended for in vitro diagnostic (IVD) use.