# Oncomine Dx Express Test

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

## TL;DR

Thermo Fisher's newer sequencing test for lung cancer, companion to sunvozertinib for EGFR exon 20 insertions and to sevabertinib for HER2 mutations.

## Summary

Life Technologies' (Thermo Fisher Scientific) Oncomine Dx Express Test was approved on 2 July 2025 (PMA P240040) as the companion diagnostic for sunvozertinib in non-small-cell lung cancer with EGFR exon 20 insertions. A supplement on 9 September 2026 added sevabertinib for HER2 (ERBB2) activating mutations: single-nucleotide variants in exons 18 to 21 of the kinase domain and exon 20 insertions. It is a separate device from the older Oncomine Dx Target Test.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: Oncomine Dx Express Test
- Modality: Tissue NGS companion diagnostic test
- Mechanism: Next-generation sequencing of lung tumour tissue (FDA generic name: next generation sequencing oncology panel, somatic or germline variant detection system).
- Approvals: US 2025: Companion diagnostic for sunvozertinib in NSCLC with EGFR exon 20 insertions; US 2026: Companion diagnostic for sevabertinib in NSCLC with HER2 activating mutations

## Sources

- FDA PMA P240040: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240040
- 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: [Oncomine Dx Target Test](https://onco.cc/drugs/oncomine-dx-target-test/), [Sevabertinib](https://onco.cc/drugs/sevabertinib/), [Sunvozertinib](https://onco.cc/drugs/sunvozertinib/)
- biomarkers: [EGFR exon 20 insertion](https://onco.cc/biomarkers/egfr-exon-20-insertion/)
- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [EGFR](https://onco.cc/targets/egfr/), [HER2](https://onco.cc/targets/her2/)
- companies: [Life Technologies](https://onco.cc/companies/life-technologies/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Next-generation sequencing (NGS)](https://onco.cc/terms/ngs/)

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JSON: https://onco.cc/api/v1/entities/oncomine-dx-express.json