Home·Explore by Test·Oncomine Dx Express Test
FDA-approved companion diagnostic

Oncomine Dx Express Test

Targeted NGS panel on the Genexus Dx system that profiles key DNA and RNA alterations in FFPE solid tumors and detects EGFR exon 20 insertions in NSCLC.

IVD-developed CDxMethod: NGSSpecimen: Tissue (FFPE)Biomarker: EGFR exon 20 insertion mutations, Multi-gene solid tumor profiling panel (46 genes)
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P240040
Supplements
Manufacturer
Life Technologies Corporation (ThermoFisher Scientific)
Approval date
July 2, 2025
Test specifications
Methodology
NGS
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
EGFR exon 20 insertion mutations, Multi-gene solid tumor profiling panel (46 genes)
What this test is

Oncomine Dx Express Test is an FDA-approved, qualitative targeted NGS assay run on the Genexus Dx Integrated Sequencer. It analyzes FFPE tumor tissue to detect substitutions, insertions, and deletions in 42 genes, copy number variants in 10 genes, and fusions or splice variants in 18 genes. The test serves as a companion diagnostic for EGFR exon 20 insertion–positive NSCLC and provides broad tumor profiling for patients with solid malignant neopl

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Non-Small Cell Lung Cancer (NSCLC)EGFR (HER1)Exon 20 insertionsZEGFROVY

IVD Manufacturer

Life Technologies Corporation (ThermoFisher Scientific)

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order forOncomine Dx Express Test directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

© 2025 Casandra.ai