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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceVENTANA PTEN (SP218) RxDx Assay
Generic NameImmunohistochemistry Assay, Antibody, phosphatase and tensin homolog (PTEN)
ApplicantVentana Medical Systems, Inc. (Roche Tissue Diagnostics)
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP250031
Date Received08/18/2025
Decision Date06/12/2026
Product Code SHF 
Docket Number 26M-6735
Notice Date 06/12/2026
Advisory Committee Pathology
Clinical TrialsNCT04493853
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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