# VENTANA PTEN (SP218) RxDx Assay

Source: https://onco.cc/drugs/ventana-pten-sp218/  
OnCo record `ventana-pten-sp218` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The stain that finds PTEN loss in hormone-sensitive prostate cancer that has spread, selecting men for capivasertib.

## Summary

Ventana Medical Systems' (Roche Tissue Diagnostics) PTEN (SP218) RxDx Assay was approved on 12 June 2026 (PMA P250031) as the companion diagnostic for capivasertib in metastatic hormone-sensitive prostate cancer with PTEN protein loss or deficiency.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: VENTANA PTEN (SP218) RxDx Assay
- Modality: Immunohistochemistry companion diagnostic assay (PTEN protein, prostate tumour tissue)
- Mechanism: Immunohistochemistry with the SP218 antibody for loss of PTEN protein in prostate tumour tissue.
- Approvals: US 2026: Companion diagnostic for capivasertib in metastatic hormone-sensitive prostate cancer with PTEN loss

## Sources

- FDA PMA P250031: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250031
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- biomarkers: [PTEN alteration (sequencing) and PTEN loss (IHC)](https://onco.cc/biomarkers/pten-alteration/)
- cancers: [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- targets: [PTEN](https://onco.cc/targets/pten/)
- drugs: [Capivasertib](https://onco.cc/drugs/capivasertib/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/)

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