# VENTANA MET (SP44) RxDx Assay

Source: https://onco.cc/drugs/ventana-met-sp44/  
OnCo record `ventana-met-sp44` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The MET protein stain that selects people with lung cancer for telisotuzumab vedotin.

## Summary

Ventana Medical Systems' (Roche Tissue Diagnostics) MET (SP44) RxDx Assay was approved on 14 May 2025 (PMA P240037) as the companion diagnostic for telisotuzumab vedotin in non-small-cell lung cancer with high MET protein expression. It measures protein, not a MET gene change, so it selects a different group from tests for MET exon 14 skipping.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: VENTANA MET (SP44) RxDx Assay
- Modality: Immunohistochemistry companion diagnostic assay (MET protein, lung tumour tissue)
- Mechanism: Immunohistochemistry with the SP44 antibody; the FDA list defines the selecting result as at least 50% of tumour cells with strong (3+) membrane and/or cytoplasmic staining.
- Approvals: US 2025: Companion diagnostic for telisotuzumab vedotin in NSCLC with MET protein overexpression

## Sources

- FDA PMA P240037: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240037
- 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: [c-Met protein overexpression (IHC 3+ in >= 50% of tumour cells)](https://onco.cc/biomarkers/met-overexpression/)
- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- targets: [MET](https://onco.cc/targets/met/)
- drugs: [Telisotuzumab vedotin](https://onco.cc/drugs/telisotuzumab-vedotin/)
- 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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