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FDA-approved companion diagnostic

Oncomine Dx Target Test

Targeted NGS assay on the Ion PGM Dx System that detects key DNA variants and RNA fusions in FFPE tumors across multiple cancers to guide targeted therapy.

IVD-developed CDxMethod: NGSSpecimen: Tissue (FFPE)Biomarker: Solid tumor driver mutations and fusions (multi-gene panel)
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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
P160045
Supplements
S019, S025, S027, S028, S029, S031, S035, S046, S049
Manufacturer
Life Technologies Corporation (ThermoFisher Scientific)
Approval date
June 22, 2017
Test specifications
Methodology
NGS
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
Solid tumor driver mutations and fusions (multi-gene panel)
What this test is

Oncomine Dx Target Test is an FDA-approved, qualitative targeted NGS assay performed on the Ion PGM Dx System. Using DNA and RNA from FFPE tumor tissue, it detects single-nucleotide variants, insertions, deletions, and fusions in a defined panel of cancer driver genes. It is approved for use in NSCLC and several other solid tumors to characterize oncogenic alterations and support selection of targeted treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Anaplastic Thyroid Cancer (ATC)BRAFV600ETAFINLAR + MEKINIST
Astrocytoma and OligodendrogliomaIDH1, IDH2IDH1 R132C, IDH1 R132G, IDH1 R132H, IDH1 R132L, IDH1 R132S, IDH2 R172M, IDH2 R172K, IDH2 R172W, IDH2 R172S, and IDH2 R172G mutationsVORANIGO
CholangiocarcinomaIDH1Single nucleotide variantsTIBSOVO
Medullary Thyroid Cancer (MTC)RETRET mutations (SNVs, MNVs, and deletions)RETEVMO
Non-Small Cell Lung Cancer (NSCLC)BRAFV600ETAFINLAR + MEKINIST
EGFR (HER1)Exon 19 deletion or exon 21 L858R substitution mutationIRESSA
Exon 20 insertionsEXKIVITY, RYBREVANT
ERBB2 (HER2)Activating Mutations (SNVs And Exon 20 Insertions)ENHERTU
Activating mutations in the tyrosine kinase domain (SNVs in exons 18-21 and exon 20 insertions)HERNEXEOS
RETfusionsGAVRETO, RETEVMO
ROS1fusionsXALKORI
Thyroid Cancer (TC)RETfusionsRETEVMO

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 Target 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.

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