# PathVysion HER-2 DNA Probe Kit

Source: https://onco.cc/drugs/pathvysion-her2/  
OnCo record `pathvysion-her2` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

One of the first HER2 gene tests, approved in December 1998 to select trastuzumab for breast cancer.

## Summary

Abbott Molecular's PathVysion HER-2 DNA Probe Kit was approved on 11 December 1998 (PMA P980024) and is listed by the FDA as a companion diagnostic for trastuzumab in breast cancer, detecting HER2 gene amplification.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: PathVysion HER-2 DNA Probe Kit
- Modality: FISH companion diagnostic test (HER2 gene amplification, breast tumour tissue)
- Mechanism: Fluorescence in situ hybridisation counting copies of the HER2 (ERBB2) gene in breast tumour cells.
- Approvals: US 1998: HER2 gene amplification to select trastuzumab in breast cancer

## Sources

- FDA PMA P980024: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980024
- 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

- drugs: [HER2 FISH pharmDx Kit](https://onco.cc/drugs/her2-fish-pharmdx/), [HER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH)](https://onco.cc/drugs/her2-testing-assays/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- biomarkers: [HER2 ISH amplified (ERBB2 gene amplification)](https://onco.cc/biomarkers/her2-ish-amplified/)
- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Cytogenetics and FISH](https://onco.cc/technologies/cytogenetics-fish/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Abbott Laboratories](https://onco.cc/companies/abbott/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [FISH / ISH (in situ hybridisation)](https://onco.cc/terms/fish/), [HER2-positive (IHC 3+ or ISH-amplified)](https://onco.cc/terms/her2-positive/)

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